Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients. Prospective Phase III Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 55
- Locations
- 3
- Primary Endpoint
- overall survival (OS)
Study Overview
Brief Summary
The aim of the study is to evaluate the efficacy of sorafenib, compared to the best supportive care (BSC), in two cohorts of patients who presented with advanced hepatocellular carcinoma (HCC) based on etiology of hepatitis C virus.
Detailed Description
In Egypt, chronic hepatitis C virus (HCV) infection occurs in around 10% of the population (about 8 million individuals), and is a leading cause of liver cirrhosis, hepatocellular carcinoma, and mortality. Although HCV genotype 4 constitutes about 20% of HCV infections worldwide, the prevalence in Egypt is more than 90%.(Waked et al., 2016)
In 2014 Omar et al. reviewed 41 patients in a study to evaluate Sorafenib for Egyptian patients with advanced hepatocellular carcinoma at a median follow up period of 13 months, the median PFS for the whole group was 4 months; the median OS for the whole group is 6.25 months.(Abdel-Rahman et al., 2014)
Till current, no studies have evaluated the Sorafenib efficacy in comparison to the best supportive care treatment in HCC patients whose etiology from HCV genotype 4 ( the most prevalent hepatitis C virus genotype in Egypt).
So, The study aims to evaluate the efficacy of sorafenib, compared to the best supportive care (BSC), in two cohorts of patients who presented with advanced hepatocellular carcinoma (HCC) based on etiology of hepatitis C virus.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ≥18 years of age
- •Patients based on etiology of hepatitis C virus.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
- •Child-Pugh liver function class A,B
- •A life expectancy of 12 weeks or more
- •adequate hematologic function (platelet count, ≥60×109 per liter; hemoglobin, ≥8.5 g per deciliter; and prothrombin time international normalized ratio, ≤2.3; or prothrombin time, ≤6 seconds above control), adequate hepatic function (albumin, ≥2.8 g per deciliter; total bilirubin, ≤3 mg per deciliter [51.3 µmol per liter]; and alanine aminotransferase and aspartate aminotransferase, ≤5 times the upper limit of the normal range), and adequate renal function (serum creatinine, ≤1.5 times the upper limit of the normal range).
- •Patients were required to have at least one untreated target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Exclusion Criteria
- •Had previously received molecularly targeted therapies or any other systemic treatment.
- •Any co morbid disease that will confuse the assessment of the Quality of life questionnaire scoreFHSI-8 score.
Arms & Interventions
HCC patients (Group 1)
Sorafenib will be administrated at a dose of 400 mg twice daily (consisting of two 200-mg tablets).Treatment interruptions and up to two dose reductions (first to 400 mg once daily and then to 400 mg every 2 days) will permitted for drug- related adverse effects. If further dose reductions will required, patients will withdraw from the study
Intervention: Sorafenib (Drug)
HCC patients (Group 2)
Patient will take best supportive care
Intervention: Best Supportive care (Drug)
Outcomes
Primary Outcomes
overall survival (OS)
Time Frame: 12 months
Overall survival is defined as the duration from the start of treatment date till date of last contact or death date.
Event free survival
Time Frame: 12 months
Event free survival was defined as the duration from the date of diagnosis till the date of first event (death, radiological progression, symptomatic progression) or the date of last contact if the patient did not develop the event.
Secondary Outcomes
- Detection of changes in quality of life(12 months)
- Sorafenib induced side effects(12 months)
Investigators
Noha El Baghdady
Ph.D Candidate
Ain Shams University