NCT02971696

Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.

Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients. Prospective Phase III Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	Sorafenib	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
DRUG	Best Supportive care	Liver Support, pain management

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-11-01
• Completion: 2018-01-01
• First posted: 2016-11-23
• Last updated: 2018-06-27

Locations

3 sites across 1 country: Egypt