Trial Outcomes & Findings for Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria (NCT NCT01141478)

Last Updated: 2021-10-15

Results Overview

All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months.

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

Change between time of informed consent and primary completion date of study, an average of 4 years per participant

Results posted on

2021-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Proton Beam Radiotherapy Plus Sorafenib A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid	Sorafenib Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid
Overall Study STARTED	4	4
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Proton Beam Radiotherapy Plus Sorafenib A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid	Sorafenib Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

8 subjects were consented. 4 to Arm A, and 4 to Arm B. However, 2 subjects (one from each arm) withdrew consent or were lost to follow up leaving 6 subjects total to be analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proton Beam Radiotherapy Plus Sorafenib n=4 Participants A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid	Sorafenib n=4 Participants Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=4 Participants	4 Participants n=4 Participants	7 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=4 Participants	4 Participants n=4 Participants	7 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=4 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=4 Participants	3 Participants n=4 Participants	6 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants
Region of Enrollment United States	4 participants n=4 Participants	4 participants n=4 Participants	8 participants n=8 Participants
Alfa-feto protein	1413.8 ng/ml STANDARD_DEVIATION 1777 • n=3 Participants • 8 subjects were consented. 4 to Arm A, and 4 to Arm B. However, 2 subjects (one from each arm) withdrew consent or were lost to follow up leaving 6 subjects total to be analyzed.	44319 ng/ml STANDARD_DEVIATION 29640.2 • n=3 Participants • 8 subjects were consented. 4 to Arm A, and 4 to Arm B. However, 2 subjects (one from each arm) withdrew consent or were lost to follow up leaving 6 subjects total to be analyzed.	22866.4 ng/ml STANDARD_DEVIATION 30082.1 • n=6 Participants • 8 subjects were consented. 4 to Arm A, and 4 to Arm B. However, 2 subjects (one from each arm) withdrew consent or were lost to follow up leaving 6 subjects total to be analyzed.

PRIMARY outcome

Timeframe: Change between time of informed consent and primary completion date of study, an average of 4 years per participant

Population: two subjects withdrew prior to over all survival rate measurement

Outcome measures

Outcome measures
Measure	Proton Beam Radiotherapy Plus Sorafenib n=3 Participants A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid	Sorafenib n=3 Participants Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid
Overall Survival Rate Between Time of Consent and Time of Death	1.6 years Interval 0.1 to 3.7	0.36 years Interval 0.3 to 0.4

Adverse Events

Proton Beam Radiotherapy Plus Sorafenib

Serious events: 1 serious events

Other events: 0 other events

Deaths: 3 deaths

Sorafenib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Proton Beam Radiotherapy Plus Sorafenib n=4 participants at risk A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Proton Beam Radiotherapy: Fifteen consecutive sessions Sorafenib: 400 mg po bid	Sorafenib n=4 participants at risk Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Sorafenib: 400 mg po bid
General disorders Death - cerebral hemorrahic stroke	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of enrollment to death or time when a patient was lost to follow-up All subjects are at risk for serious and non serious adverse events due to the progression of their liver disease and the possible side effects from both study treatment arms.	0.00% 0/4 • Adverse events were collected from time of enrollment to death or time when a patient was lost to follow-up All subjects are at risk for serious and non serious adverse events due to the progression of their liver disease and the possible side effects from both study treatment arms.

Other adverse events

Adverse event data not reported

Additional Information

Diane Scavone, research coordinator

Loma Linda University Medical Center

Phone: 909 558-3636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place