Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.

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

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.

Study Overview

• Status: Completed
• Conditions: HCC
• Intervention / Treatment: Drug: Sorafenib; Drug: Best Supportive care

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Nasser Institute
  • Cairo, Egypt
    • Ain Shams University Hospital
  • N/A = Not Applicable
    • Cairo, N/A = Not Applicable, Egypt, 1234
      • El Kahraba Hosital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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; Other Names: nexavar
ACTIVE_COMPARATOR: HCC patients (Group 2); Patient will take best supportive care	Drug: Best Supportive care; Liver Support, pain management; Other Names: Liver Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	Overall survival is defined as the duration from the start of treatment date till date of last contact or death date.	12 months
Event free survival	Event free survival was defined as the duration from the date of diagnosis till the date of first event (death, radiological progression, symptomatic progression) or the date of last contact if the patient did not develop the event.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of changes in quality of life	through application of QLQ FHSI-8 questionnaire every two months in both arms	12 months
Sorafenib induced side effects	incidence and severity	12 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: AbdelRahman Elnaggar, Prof., MTI University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 20, 2016
• First Posted (ESTIMATE): November 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: 40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO