Clinical trial · Interventional
Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma
NCT01932385CI-TRIAL-00031685completedPhase 2 / Phase 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)
Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Supportive Care | Other | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- sorafenib
- description
- sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.
- interventionNames
- Drug: Sorafenib
- Other: Best Supportive Care
- type
- ACTIVE_COMPARATOR
- label
- Best Supportive Care
- description
- treatment mainly on nutrition and symptoms control
- interventionNames
- Other: Best Supportive Care
Primary outcomes (1)
- measure
- progression free survival and overall survival
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * pathological or cytological confirmed advanced hepatocellular carcinoma * 18 years to 80 years * liver function Child-Pugh class B * BCLC stage B or C * estimated life time 2 months or longer Exclusion Criteria: * previous target therapy * allergy to Sorafenib * Uncontrolled Bleeding or diarrhea * eligible for locoregional treatment
References
Publications (0)
Data not yet available
No reference posted for this study.