Carcinoma, Hepatocellular
Conditions
Keywords
Carcinoma, Hepatocellular, Proton Beam Radiotherapy, Sorafenib
Brief summary
This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.
Interventions
RADIATIONProton Beam Radiotherapy
Fifteen consecutive sessions
DRUGSorafenib
400 mg po bid
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients are candidates to receive both proton beam and sorafenib 2. Patients with tumor burden that exceeds San Francisco criteria
Exclusion criteria
1. Patients who are candidates for surgical resection 2. Patients with tumor burden within Milan and/or San Francisco criteria 3. Patients who have contraindication to receive proton 4. Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug 5. Patients treated previously by any locoregional treatment 6. Patients with prior liver transplant 7. Patients with child class C 8. Patients with model for end-stage liver disease (MELD) score of \> 25 9. Patients with other comorbid diseases that may impact survival 10. Patients with ongoing alcohol intake 11. Patients with active sepsis 12. Patients with gastrointestinal bleeding within a week 13. Patients unwilling to sign informed consent form 14. Patients with history of noncompliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate Between Time of Consent and Time of Death | Change between time of informed consent and primary completion date of study, an average of 4 years per participant | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| Sorafenib Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.
Sorafenib: 400 mg po bid | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Proton Beam Radiotherapy Plus Sorafenib | Sorafenib |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 3 Participants | 4 Participants |
| Alfa-feto protein | 22866.4 ng/ml STANDARD_DEVIATION 30082.1 | 1413.8 ng/ml STANDARD_DEVIATION 1777 | 44319 ng/ml STANDARD_DEVIATION 29640.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 3 Participants | 3 Participants |
| Region of Enrollment United States | 8 participants | 4 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 4 | 3 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 1 / 4 | 0 / 4 |
Outcome results
Primary
Overall Survival Rate Between Time of Consent and Time of Death
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Proton Beam Radiotherapy Plus Sorafenib | Overall Survival Rate Between Time of Consent and Time of Death | 1.6 years |
| Sorafenib | Overall Survival Rate Between Time of Consent and Time of Death | 0.36 years |