Clinical trial · Interventional
Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma
Sorafenib in the First Line Treatment of Advanced Hepatocellular Carcinoma With Child-Pugh Liver Function Class B: Multicentre Phase 3 Randomized Trial
NCT01405573CI-TRIAL-00026651BOOSTterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of enrolment
Summary
Brief summary (as posted)
The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best supportive care with best supportive care alone in terms of survival in patients with hepatocellular carcinoma (HCC) with impaired liver function (Child B).
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 |
|---|---|---|---|
| Advanced Adult Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Supportive Care | Other | — | UNRESOLVED |
| sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Best Supportive Care
- description
- best supportive care
- interventionNames
- Other: Best Supportive Care
- type
- EXPERIMENTAL
- label
- B: Sorafenib 400 mg, twice a day + Best Supportive Care
- description
- sorafenib + best supportive care
- interventionNames
- Other: Best Supportive Care
- Drug: sorafenib
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of hepatic cell carcinoma (HCC) according to the AASLD- EASL criteria * Age \>18 years * Advanced stage of disease defined as HCC not eligible for locoregional treatments (ab initio or following progression after such treatments) * Liver function classified as Child-Pugh class B * ECOG performance status \< or = 2 * Life expectancy of at least 2 months * Adequate contraception for fertile male and female patients * Signed informed consent Exclusion Criteria: * Prior exposure to sorafenib or antiangiogenesis drugs * Concomitant diseases that contraindicate the use of sorafenib * Gastro-intestinal bleeding in the previous 30 days * Altered renal function(creatinine \> 1.5 x ULN), or haematological function (platelet count \< 60 x 10\^9/L, hemoglobin \< 9 g/dl) * Serious active infections (\> grade 2 CTCAE version 3.0) * Congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia * Patients who are unable or unwilling to participate in the study * Pregnant or lactating females * Hepatic encephalopathy of any grade
References
Publications (0)
Data not yet available
No reference posted for this study.