Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.

NCT ID: NCT02971696

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-01-31

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.

Conditions

HCC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: 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

HCC patients (Group 2)

Patient will take best supportive care

Group Type: ACTIVE_COMPARATOR

Best Supportive care

Intervention Type: DRUG

Liver Support, pain management

Interventions

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

Intervention Type: DRUG

Best Supportive care

Liver Support, pain management

Intervention Type: DRUG

Other Intervention Names

nexavar; Liver Support

Eligibility Criteria

Inclusion Criteria

1. Patients ≥18 years of age

2. Patients based on etiology of hepatitis C virus.

3. Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less

4. Child-Pugh liver function class A,B

5. A life expectancy of 12 weeks or more

6. 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).

7. 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

1. Had previously received molecularly targeted therapies or any other systemic treatment.

2. Any co morbid disease that will confuse the assessment of the Quality of life questionnaire scoreFHSI-8 score.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Noha El Baghdady

Ph.D Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AbdelRahman Elnaggar, Prof.

Role: STUDY_CHAIR

MTI University

Locations

El Kahraba Hosital

Cairo, N/A = Not Applicable, Egypt

Ain Shams University Hospital

Cairo, , Egypt

Nasser Institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

40

Identifier Type: -

Identifier Source: org_study_id