Back to resultsSorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.
Primary Purpose
HCC
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Sorafenib
Best Supportive care
Sponsored by
About this trial
This is an interventional treatment trial for HCC
Eligibility Criteria
Inclusion Criteria:
- Patients ≥18 years of age
- Patients based on etiology of hepatitis C virus.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
- Child-Pugh liver function class A,B
- A life expectancy of 12 weeks or more
- 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).
- 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:
- Had previously received molecularly targeted therapies or any other systemic treatment.
- Any co morbid disease that will confuse the assessment of the Quality of life questionnaire scoreFHSI-8 score.
Sites / Locations
- El Kahraba Hosital
- Ain Shams University Hospital
- Nasser Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HCC patients (Group 1)
HCC patients (Group 2)
Arm Description
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
Patient will take best supportive care
Outcomes
Primary Outcome Measures
overall survival (OS)
Overall survival is defined as the duration from the start of treatment date till date of last contact or death date.
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.
Secondary Outcome Measures
Detection of changes in quality of life
through application of QLQ FHSI-8 questionnaire every two months in both arms
Sorafenib induced side effects
incidence and severity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02971696
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCC patients (Group 1)
Arm Type
Experimental
Arm Description
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
Arm Title
HCC patients (Group 2)
Arm Type
Active Comparator
Arm Description
Patient will take best supportive care
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
nexavar
Intervention Description
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
Intervention Name(s)
Best Supportive care
Other Intervention Name(s)
Liver Support
Intervention Description
Liver Support, pain management
Primary Outcome Measure Information:
Title
overall survival (OS)
Description
Overall survival is defined as the duration from the start of treatment date till date of last contact or death date.
Time Frame
12 months
Title
Event free survival
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Detection of changes in quality of life
Description
through application of QLQ FHSI-8 questionnaire every two months in both arms
Time Frame
12 months
Title
Sorafenib induced side effects
Description
incidence and severity
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients ≥18 years of age
Patients based on etiology of hepatitis C virus.
Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
Child-Pugh liver function class A,B
A life expectancy of 12 weeks or more
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).
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:
Had previously received molecularly targeted therapies or any other systemic treatment.
Any co morbid disease that will confuse the assessment of the Quality of life questionnaire scoreFHSI-8 score.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbdelRahman Elnaggar, Prof.
Organizational Affiliation
MTI University
Official's Role
Study Chair
Facility Information:
Facility Name
El Kahraba Hosital
City
Cairo
State/Province
N/A = Not Applicable
ZIP/Postal Code
1234
Country
Egypt
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt
Facility Name
Nasser Institute
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.
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