Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Radiation: Proton Beam Radiotherapy
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are candidates to receive both proton beam and sorafenib Patients with tumor burden that exceeds San Francisco criteria Exclusion Criteria: Patients who are candidates for surgical resection Patients with tumor burden within Milan and/or San Francisco criteria Patients who have contraindication to receive proton Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug Patients treated previously by any locoregional treatment Patients with prior liver transplant Patients with child class C Patients with model for end-stage liver disease (MELD) score of > 25 Patients with other comorbid diseases that may impact survival Patients with ongoing alcohol intake Patients with active sepsis Patients with gastrointestinal bleeding within a week Patients unwilling to sign informed consent form Patients with history of noncompliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proton Beam Radiotherapy plus Sorafenib<br>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. | Radiation: Proton Beam Radiotherapy<br>* Fifteen consecutive sessions<br>Drug: Sorafenib<br>* 400 mg po bid<br>|
| Active Comparator: Sorafenib<br>Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. | Drug: Sorafenib<br>* 400 mg po bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change between time of informed consent and primary completion date of study, an average of 4 years per participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Hepatocellular, Proton Beam Radiotherapy, Sorafenib