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

Loma Linda University8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Hepatocellular

Interventions

Proton Beam RadiotherapyRADIATION

Fifteen consecutive sessions

SorafenibDRUG

400 mg po bid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Loma Linda University Medical Center

Loma Linda, California, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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