Clinical trial NCT02971696: Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.
Official title: Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients. Prospective Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HCC
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: overall survival (OS)
timeFrame: 12 months
measure: Event free survival
timeFrame: 12 months
Secondary outcomes:
measure: Detection of changes in quality of life
timeFrame: 12 months
measure: Sorafenib induced side effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El Kahraba Hosital
state: N/A = Not Applicable
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
city: Cairo
country: Egypt
facility: Nasser Institute
Study officials:
affiliation: MTI University
name: AbdelRahman Elnaggar, Prof.
role: STUDY_CHAIR
References: