Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.
NCT02971696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2018-06-27
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.
Conditions
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
Ain Shams University
lead OTHER
Principal Investigators
-
AbdelRahman Elnaggar, Prof. · MTI University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-31
- Primary Completion
- 2017-11-30
- Completion
- 2018-01-31
Countries
- Egypt
Study Locations
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