Clinical trial · Interventional
Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients.
Sorafenib Versus Best Supportive Care in Egyptian Hepatocellular Carcinoma Patients. Prospective Phase III Study
NCT02971696CI-TRIAL-00033463completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Supportive care | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HCC patients (Group 1)
- 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
- interventionNames
- Drug: Sorafenib
- type
- ACTIVE_COMPARATOR
- label
- HCC patients (Group 2)
- description
- Patient will take best supportive care
- interventionNames
- Drug: Best Supportive care
Primary outcomes (2)
- measure
- overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.