Trial Outcomes & Findings for Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery (NCT NCT00956930)

Last Updated: 2022-11-21

Results Overview

Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression. Patients have repeat imaging done (MRI or CT) at 1-month post procedure and then every 3 months after that. TTP and overall survival (OS) analyses were calculated from day of randomization by Kaplan-Meier analysis on intention-to-treat (ITT) basis. Progression (which is detected on follow-up imaging scans) was defined as: 1. Progression by World Health Organization (WHO) response criteria 25% increase in bidimensional cross product. 2. Progression by European Assosciation for the Study of the Liver (EASL): 25% increase in arterial enhancement 3. Malignant portal vein tumor thrombus development 4. Index lesion: lesions requiring re-treatment because of worsening circumferential enhancement 5. Development of new lesions or extra-hepatic metastases.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Up to 6 yrs

Results posted on

2022-11-21

Participant Flow

All BCLC stage HCC patients were reviewed by the multidisciplinary tumor board(transplant surgery, hepatology, medical oncology, and interventional radiology) between October 2009 and October 2015.

179 patients BCLC A/B patients were eligible. 43 declined to participate, 29 selected other clinical trials, 49 requested Y90 and 13 requested cTACE. 45 agreed to be randomized.

Participant milestones

Participant milestones
Measure	Arm I (Radioembolization) Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses. yttrium Y 90 glass microspheres: Patients undergo radioembolization.	Arm II (Transarterial Chemoembolization [TACE]) Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses. Doxorubicin: 75mg fixed dose
Overall Study STARTED	24	21
Overall Study COMPLETED	24	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Radioembolization) n=24 Participants Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses. yttrium Y 90 glass microspheres: Patients undergo radioembolization.	Arm II (Transarterial Chemoembolization [TACE]) n=21 Participants Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses. Doxorubicin: 75mg fixed dose	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	13 Participants n=4 Participants	29 Participants n=27 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Age, Continuous	62 years n=93 Participants	64 years n=4 Participants	64 years n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	16 Participants n=4 Participants	33 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	19 Participants n=93 Participants	16 Participants n=4 Participants	35 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	24 participants n=93 Participants	21 participants n=4 Participants	45 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 6 yrs

Outcome measures

Outcome measures
Measure	Arm I (Radioembolization) n=24 Participants Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses. yttrium Y 90 glass microspheres: Patients undergo radioembolization.	Arm II (Transarterial Chemoembolization [TACE]) n=21 Participants Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses. Doxorubicin: 75mg fixed dose
Time to Progression (TTP) in Patients Treated With TACE and Y90	26 Months Interval 14.5 to 26.0	6.8 Months Interval 3.2 to 9.1

SECONDARY outcome

Timeframe: up to 6 years

Repeat imaging (CT/MRI) and lab work including tumor markers will be assessed 1 month post-treatment then every 3 months after that. Both EASL \& WHO criteria are used. By EASL criteria Complete response is 100% Decrease in amount of enhancing tissue in index lesion, Partial response is ≥50% deecrease in amount of enhancing tissue in index lesion, Stable disease is \<50% Decrease in to ≤ 25% increase in amount of enhancing tissue in index lesion, Progressive disease \<25% Increase in amount of enhancing tissue in index lesion and/or new enhancement in previously treated index lesion.

Outcome measures

Outcome measures
Measure	Arm I (Radioembolization) n=23 Participants Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses. yttrium Y 90 glass microspheres: Patients undergo radioembolization.	Arm II (Transarterial Chemoembolization [TACE]) n=19 Participants Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses. Doxorubicin: 75mg fixed dose
Number of Patients Who Achieved Complete or Partial Radiologic Response After Treatment Complete & Partial Response Rate by EASL criteria	20 Participants	14 Participants
Number of Patients Who Achieved Complete or Partial Radiologic Response After Treatment Stable Disease and progressive disease by EASL cri	3 Participants	5 Participants

SECONDARY outcome

Timeframe: From day of randomization until date of death, or liver transplant or 7/15/2016, whichever came first, assessed up to 6 years

Comparing overall survival of both treatment arms.

Outcome measures

Outcome measures
Measure	Arm I (Radioembolization) n=24 Participants Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses. yttrium Y 90 glass microspheres: Patients undergo radioembolization.	Arm II (Transarterial Chemoembolization [TACE]) n=21 Participants Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses. Doxorubicin: 75mg fixed dose
Overall Survival	18.6 Months Interval 7.4 to 32.5	17.7 Months Interval 8.3 to 27.9

Adverse Events

Arm I (Radioembolization)

Serious events: 6 serious events

Other events: 24 other events

Deaths: 9 deaths

Arm II (Transarterial Chemoembolization [TACE])

Serious events: 3 serious events

Other events: 19 other events

Deaths: 11 deaths

Serious adverse events

Other adverse events

Additional Information

Riad Salem MD

Northwestern University

Phone: 312-695-6371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Arm I (Radioembolization) n=24 participants at risk Patients undergo radioembolization with yttrium-90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.	Arm II (Transarterial Chemoembolization [TACE]) n=19 participants at risk Patients undergo chemoembolization (TACE) with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses. Doxorubicin: 75mg fixed dose
Hepatobiliary disorders Abdominal Pain	4.2% 1/24 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
General disorders Fatigue	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
General disorders Nausea	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Gastrointestinal disorders Vomiting	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
General disorders Fever	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Gastrointestinal disorders Anorexia	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Gastrointestinal disorders Constipation	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Gastrointestinal disorders Diarrhea	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Hypoalbuminemia	4.2% 1/24 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Hyperbilirubinemia	8.3% 2/24 • Number of events 2 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	5.3% 1/19 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Alkaline Phosphatase toxicity	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Alanine aminotransferase toxicity	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Aspartate aminotransferase toxicity	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	10.5% 2/19 • Number of events 2 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Blood and lymphatic system disorders leukopenia	4.2% 1/24 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Blood and lymphatic system disorders Neutropenia	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	10.5% 2/19 • Number of events 2 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Liver Decompensation	12.5% 3/24 • Number of events 3 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	5.3% 1/19 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Skin and subcutaneous tissue disorders cellulitis	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	5.3% 1/19 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Renal and urinary disorders Hypokalemia	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	5.3% 1/19 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
General disorders Sepsis	8.3% 2/24 • Number of events 2 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	5.3% 1/19 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.

Other adverse events
Measure	Arm I (Radioembolization) n=24 participants at risk Patients undergo radioembolization with yttrium-90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.	Arm II (Transarterial Chemoembolization [TACE]) n=19 participants at risk Patients undergo chemoembolization (TACE) with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses. Doxorubicin: 75mg fixed dose
General disorders Fatigue	87.5% 21/24 • Number of events 21 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	63.2% 12/19 • Number of events 12 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Abdominal Pain	25.0% 6/24 • Number of events 6 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	52.6% 10/19 • Number of events 10 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
General disorders Nausea	29.2% 7/24 • Number of events 7 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	42.1% 8/19 • Number of events 8 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Gastrointestinal disorders Vomiting	4.2% 1/24 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	15.8% 3/19 • Number of events 3 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
General disorders Fever	4.2% 1/24 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	15.8% 3/19 • Number of events 3 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Gastrointestinal disorders Anorexia	25.0% 6/24 • Number of events 6 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	21.1% 4/19 • Number of events 4 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Gastrointestinal disorders Constipation	4.2% 1/24 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	0.00% 0/19 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Gastrointestinal disorders Diarrhea	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	21.1% 4/19 • Number of events 4 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Hypoalbuminemia	4.2% 1/24 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	57.9% 11/19 • Number of events 11 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Bilirubinemia	25.0% 6/24 • Number of events 6 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	26.3% 5/19 • Number of events 5 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Alkaline Phosphatase toxicity	25.0% 6/24 • Number of events 6 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	10.5% 2/19 • Number of events 2 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Alanine aminotransferase toxicity	12.5% 3/24 • Number of events 3 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	21.1% 4/19 • Number of events 4 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Hepatobiliary disorders Aspartate aminotransferase toxicity	20.8% 5/24 • Number of events 5 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	36.8% 7/19 • Number of events 7 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Blood and lymphatic system disorders Leukopenia	4.2% 1/24 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	10.5% 2/19 • Number of events 2 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.
Blood and lymphatic system disorders Neutropenia	0.00% 0/24 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.	5.3% 1/19 • Number of events 1 • The study period included patients treated between October 2009 and June 2016. Patients were followed-up date of treatment up to date of last imaging, death or study closure, approximately 6 years Pts were followed up to date of last imaging, death, study closure (6 years). SAEs were reported if pts developed grade 3 or higher. Non SAEs reported if \>1 pts developed grade 1-2. Two patients from arm II had follow-up at an outside hospital, both imaging and adverse-event related data were not available for us to include in the analyses. All efforts were made to obtain the data. Hence, they could not be included in the imaging/AE analysis. However, we were able to obtain survival status.