Trial Outcomes & Findings for Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer (NCT NCT01730937)

NCT ID: NCT01730937

Last Updated: 2025-10-10

Results Overview

An event for overall survival (OS) is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 153 deaths were reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 193 participants
• Primary outcome timeframe: From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
• Results posted on: 2025-10-10

Participant Flow

Participant milestones

Measure	Sorafenib Alone 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	97	96
Overall Study Eligible Population	92	85
Overall Study Adverse Event Population	88	83
Overall Study Quality of Life Population	46	37
Overall Study COMPLETED	92	85
Overall Study NOT COMPLETED	5	11

Reasons for withdrawal

Measure	Sorafenib Alone 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Overall Study Protocol Violation	5	11

Baseline Characteristics

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

Baseline characteristics by cohort

Measure	Sorafenib Alone n=92 Participants 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib n=85 Participants 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	Total n=177 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	66 years n=7 Participants	66 years n=5 Participants
Age, Customized ≤ 49 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized 50 - 59 years	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized 60 - 69 years	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
Age, Customized 70 - 79 years	26 Participants n=5 Participants	18 Participants n=7 Participants	44 Participants n=5 Participants
Age, Customized ≥ 80 years	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	68 Participants n=7 Participants	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	47 Participants n=7 Participants	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	59 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Zubrod performance status 0	41 Participants n=5 Participants	47 Participants n=7 Participants	88 Participants n=5 Participants
Zubrod performance status 1	44 Participants n=5 Participants	33 Participants n=7 Participants	77 Participants n=5 Participants
Zubrod performance status 2	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
T Stage T1	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
T Stage T2	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
T Stage T3a	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
T Stage T3b	49 Participants n=5 Participants	38 Participants n=7 Participants	87 Participants n=5 Participants
T Stage T4	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
N Stage N0	89 Participants n=5 Participants	80 Participants n=7 Participants	169 Participants n=5 Participants
N Stage N1	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
N Stage NX	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
M Stage M0	88 Participants n=5 Participants	82 Participants n=7 Participants	170 Participants n=5 Participants
M Stage M1	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Child Pugh Score 5 (Grade A)	69 Participants n=5 Participants	64 Participants n=7 Participants	133 Participants n=5 Participants
Child Pugh Score 6 (Grade A)	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
BCLC Stage Intermediate (B)	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
BCLC Stage Advanced (C)	77 Participants n=5 Participants	68 Participants n=7 Participants	145 Participants n=5 Participants
Hepatocellular carcinoma (HCC) tumor volume / liver volume <10%	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Hepatocellular carcinoma (HCC) tumor volume / liver volume 10-40%	42 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants
Hepatocellular carcinoma (HCC) tumor volume / liver volume >40%	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Hepatitis Status Hepatitis B or B and C	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Hepatitis Status Hepatitis C	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Hepatitis Status Other	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Enhancing vascular thrombosis Yes	66 Participants n=5 Participants	62 Participants n=7 Participants	128 Participants n=5 Participants
Enhancing vascular thrombosis No	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment North America	90 Participants n=5 Participants	85 Participants n=7 Participants	175 Participants n=5 Participants
Region of Enrollment Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.

Population: Eligible participants

An event for overall survival (OS) is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 153 deaths were reported.

Outcome measures

Measure	Sorafenib Alone n=92 Participants 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib n=85 Participants 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Overall Survival	12.30 months Interval 10.62 to 14.3	15.85 months Interval 11.42 to 19.15

SECONDARY outcome

Timeframe: From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.

Population: Eligible participants

Progression (failure) is defined as any of the following events: new tumor thrombosis, progression of hepatocellular carcinoma (HCC) within liver excluding tumor thrombosis status, progression of distant metastases that were present at study entry, new HCC within the liver including tumor thrombosis, and vascular thrombosis events=progression-new enhancing tumor thrombosis/progression-Increase in the volume of enhancing portion of thrombosis. Time to progression was measured from the date of randomization to the date of first failure, death (competing risk), or last follow-up (censored). Progression rates are estimated by the cumulative incidence method. The protocol specifies only that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided as a summary of the distributions.

Outcome measures

Measure	Sorafenib Alone n=92 Participants 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib n=85 Participants 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Time to Progression	66.3 percentage of participants Interval 55.3 to 75.3	56.4 percentage of participants Interval 44.9 to 66.4

SECONDARY outcome

Timeframe: From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.

Population: Eligible participants

Failure for progression-free survival (PFS) include death, new tumor thrombosis, progression of hepatocellular carcinoma (HCC) within liver excluding tumor thrombosis status, progression of distant Mets that were present at study entry, new HCC within liver including tumor thrombosis, and vascular thrombosis events =progression-new enhancing tumor thrombosis/progression-Increase in the volume of enhancing portion of thrombosis. PFS time is defined as the time from randomization to the date of first failure, date of death, or last known follow-up (censored). PFS rates are estimated by the Kaplan-Meier method. The protocol specifies only that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided as a summary of the distributions.

Outcome measures

Measure	Sorafenib Alone n=92 Participants 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib n=85 Participants 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	5.49 percentage of participants Interval 3.42 to 6.28	9.22 percentage of participants Interval 7.53 to 11.89

SECONDARY outcome

Timeframe: From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.

Population: Eligible, started treatment, and were assessed for adverse events.

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Outcome measures

Measure	Sorafenib Alone n=88 Participants 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib n=83 Participants 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Number of Participants by Highest Grade Adverse Event Reported Grade 2	21 Participants	20 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 3	49 Participants	51 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 4	10 Participants	9 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 5	6 Participants	2 Participants
Number of Participants by Highest Grade Adverse Event Reported Grade 1	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Eligible participants who consented to the quality of life component and had data at baseline and six months.

The FACT-Hep total score measures quality of life in patients with hepatobiliary cancer. Possible scores range from 0 to 180, with higher scores indicating a better outcome. Improvement in FACT-Hep total score is defined as an increase from the baseline to 6-month score of at least 5 points.

Outcome measures

Measure	Sorafenib Alone n=20 Participants 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib n=17 Participants 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Percentage of Participants With Improvement in the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Total Score 6 Months After the Start of Treatment	10 percentage of participants Interval 2.0 to 31.0	35 percentage of participants Interval 17.0 to 59.0

SECONDARY outcome

Timeframe: From randomization to last follow-up. Imaging occurs every 3 months for two years then every six months. Maximum follow-up at time of analysis was 7.6 years.

Population: Eligible participants who had vascular thrombosis at study entry

Complete response: Complete resolution of thrombosis, with recanalization of vessel.

Partial response (PR):

• Partial recanalization (if prior complete blockage)
• Unequivocal reduction in the maximal girth
• Unequivocal reduction in the volume, or elimination, of arterial enhancing portion

Progressive disease (PD): any unequivocal, unambiguous

• New enhancing tumor thrombosis
• Increase in the volume of enhancing portion
• Unequivocal progression of thrombosis (non-measurable disease), the increase in overall tumor burden (enhancing thrombosis) must be comparable to the increase required for the Response Evaluation Criteria in Solid Tumor 1.1 definition of PD of measurable disease (e.g. ≥ 73% increase in volume, which is similar to 20% increase in diameter, and at least a 5 mm absolute increase).

Stable disease:

• No/small changes that do not meet the above criteria for PR or PD
• Increase in the volume of non-enhancing thrombosis
• New bland non-enhancing thrombosis

Outcome measures

Measure	Sorafenib Alone n=66 Participants 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib n=62 Participants 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Best Vascular Thrombosis Response up to the Time of Progressive Disease (if Applicable) Complete Response	0 Participants	2 Participants
Best Vascular Thrombosis Response up to the Time of Progressive Disease (if Applicable) Partial Response	6 Participants	22 Participants
Best Vascular Thrombosis Response up to the Time of Progressive Disease (if Applicable) Stable Disease	25 Participants	23 Participants
Best Vascular Thrombosis Response up to the Time of Progressive Disease (if Applicable) Progressive Disease	14 Participants	4 Participants
Best Vascular Thrombosis Response up to the Time of Progressive Disease (if Applicable) Unknown	21 Participants	11 Participants

SECONDARY outcome

Timeframe: The EQ-5D-5L is administered at baseline, six months and one year.

Population: The protocol states that this endpoint would be addressed if and only if the primary endpoint supports the primary hypothesis, therefore data is not reported.

Quality adjusted life years is calculated as the weighted sum of the number of years spent in different health states. The weight value is a utility score between 0 (worst health state) and 1 (best health state) derived from the EQ-5D-5L questionnaire, designed to describe and value health based on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Outcome measures

Outcome data not reported

Adverse Events

Sorafenib Alone

Serious events: 20 serious events

Other events: 88 other events

Deaths: 80 deaths

SBRT Followed by Sorafenib

Serious events: 19 serious events

Other events: 83 other events

Deaths: 73 deaths

Serious adverse events

Measure	Sorafenib Alone n=88 participants at risk 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib n=83 participants at risk 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Cardiac disorders Myocardial infarction	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Abdominal pain	2.3% 2/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	2.4% 2/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Ascites	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	2.4% 2/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Duodenal perforation	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	3.6% 3/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Pancreatitis	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
General disorders Death NOS	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
General disorders Flu like symptoms	2.3% 2/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Hepatobiliary disorders Cholecystitis	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Hepatobiliary disorders Hepatic failure	4.5% 4/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Hepatobiliary disorders Hepatic hemorrhage	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Infections and infestations Bone infection	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Infections and infestations Infections and infestations - Other, specify	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	2.4% 2/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Infections and infestations Lung infection	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Infections and infestations Peritoneal infection	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Infections and infestations Sepsis	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Infections and infestations Upper respiratory infection	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Infections and infestations Urinary tract infection	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Injury, poisoning and procedural complications Fall	2.3% 2/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Alanine aminotransferase increased	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Aspartate aminotransferase increased	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Blood bilirubin increased	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	2.4% 2/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hyponatremia	2.3% 2/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Nervous system disorders Encephalopathy	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Renal and urinary disorders Acute kidney injury	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Skin and subcutaneous tissue disorders Skin ulceration	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Vascular disorders Hypotension	1.1% 1/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	0.00% 0/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Vascular disorders Thromboembolic event	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Vascular disorders Visceral arterial ischemia	0.00% 0/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.

Other adverse events

Measure	Sorafenib Alone n=88 participants at risk 400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.	SBRT Followed by Sorafenib n=83 participants at risk 27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	28.4% 25/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	53.0% 44/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Abdominal distension	11.4% 10/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	3.6% 3/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Abdominal pain	33.0% 29/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	33.7% 28/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Ascites	8.0% 7/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	13.3% 11/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Bloating	2.3% 2/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	9.6% 8/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Constipation	23.9% 21/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	19.3% 16/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Diarrhea	48.9% 43/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	45.8% 38/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	17.0% 15/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	22.9% 19/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Gastrointestinal pain	5.7% 5/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	6.0% 5/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Mucositis oral	8.0% 7/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	7.2% 6/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Nausea	31.8% 28/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	44.6% 37/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Gastrointestinal disorders Vomiting	10.2% 9/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	21.7% 18/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
General disorders Edema limbs	13.6% 12/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	16.9% 14/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
General disorders Fatigue	62.5% 55/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	65.1% 54/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
General disorders Fever	8.0% 7/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	3.6% 3/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
General disorders General disorders and administration site conditions - Other, specify	11.4% 10/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	16.9% 14/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
General disorders Pain	6.8% 6/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	9.6% 8/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Infections and infestations Infections and infestations - Other, specify	5.7% 5/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	4.8% 4/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Activated partial thromboplastin time prolonged	2.3% 2/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	6.0% 5/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Alanine aminotransferase increased	35.2% 31/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	48.2% 40/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Alkaline phosphatase increased	15.9% 14/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	26.5% 22/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Aspartate aminotransferase increased	51.1% 45/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	49.4% 41/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Blood bilirubin increased	55.7% 49/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	65.1% 54/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Creatinine increased	9.1% 8/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	4.8% 4/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations INR increased	9.1% 8/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	22.9% 19/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Investigations - Other, specify	19.3% 17/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	28.9% 24/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Lymphocyte count decreased	9.1% 8/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	21.7% 18/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Neutrophil count decreased	18.2% 16/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	22.9% 19/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Platelet count decreased	55.7% 49/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	75.9% 63/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations Weight loss	25.0% 22/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	22.9% 19/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Investigations White blood cell decreased	18.2% 16/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	45.8% 38/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Anorexia	44.3% 39/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	41.0% 34/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hyperglycemia	11.4% 10/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	20.5% 17/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	45.5% 40/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	49.4% 41/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hypocalcemia	22.7% 20/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	21.7% 18/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hypokalemia	4.5% 4/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	6.0% 5/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hypomagnesemia	19.3% 17/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	20.5% 17/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hyponatremia	31.8% 28/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	19.3% 16/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Hypophosphatemia	36.4% 32/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	38.6% 32/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	17.0% 15/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	18.1% 15/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Musculoskeletal and connective tissue disorders Back pain	10.2% 9/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	3.6% 3/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.7% 5/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	3.6% 3/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	15.9% 14/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	20.5% 17/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	8.0% 7/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	3.6% 3/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Nervous system disorders Dysgeusia	4.5% 4/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	6.0% 5/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Nervous system disorders Headache	13.6% 12/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	8.4% 7/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Nervous system disorders Nervous system disorders - Other, specify	5.7% 5/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	1.2% 1/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Psychiatric disorders Insomnia	14.8% 13/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	8.4% 7/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.3% 2/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	6.0% 5/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Cough	10.2% 9/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	14.5% 12/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.0% 7/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	14.5% 12/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.3% 2/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	6.0% 5/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	4.5% 4/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	7.2% 6/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Skin and subcutaneous tissue disorders Alopecia	5.7% 5/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	7.2% 6/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Skin and subcutaneous tissue disorders Dry skin	11.4% 10/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	9.6% 8/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	31.8% 28/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	25.3% 21/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Skin and subcutaneous tissue disorders Pruritus	11.4% 10/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	10.8% 9/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	23.9% 21/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	20.5% 17/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	26.1% 23/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	16.9% 14/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.
Vascular disorders Hypertension	27.3% 24/88 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.	24.1% 20/83 • From randomization to last follow-up: weekly during SBRT, after SBRT and before starting sorafenib, monthly during sorafenib, and overall from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years. All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment, and were assessed for adverse events.

Additional Information

Wendy Seiferheld

NRG Oncology

Phone: 2155743208

Email: seiferheldw@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
• Publication restrictions are in place

Restriction type: OTHER