Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Niacinamide; Sorafenib

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.