Status:
TERMINATED
Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria
Lead Sponsor:
Loma Linda University
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Patients are candidates to receive both proton beam and sorafenib
- Patients with tumor burden that exceeds San Francisco criteria
Exclusion
- 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
Key Trial Info
Start Date :
September 8 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01141478
Start Date
September 8 2010
End Date
June 10 2016
Last Update
October 15 2021
Active Locations (1)
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1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354