Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.

NCT02971696 | Completed Phase 3 DMC

• 1 other identifier: 40
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

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.

Conditions

HCC

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Detection of changes in quality of life

  12 months

• Sorafenib induced side effects

  12 months

Study Arms (2)

HCC patients (Group 1)

EXPERIMENTAL

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

HCC patients (Group 2)

ACTIVE COMPARATOR

Patient will take best supportive care

Drug: Best Supportive care

Interventions

Sorafenib 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

Also known as: nexavar

HCC patients (Group 1)

Best Supportive care DRUG

Liver Support, pain management

Also known as: Liver Support

HCC patients (Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (3)

El Kahraba Hosital

Cairo, N/A = Not Applicable, 1234, Egypt

Location

Ain Shams University Hospital

Cairo, Egypt

Location

Nasser Institute

Cairo, Egypt

Location

MeSH Terms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• AbdelRahman Elnaggar, Prof.

  MTI University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D Candidate

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 23, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)