Clinical trial · Interventional
A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
A Multicenter, Randomized, Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Brivanib Alaninate (ZL-2301) Combined With Best Supportive Care (BSC) and Pharmacokinetic Profiles of Brivanib Alaninate in Patients With Advanced Hepatocellular Carcinoma (HCC) Failed or Intolerant of Standard Systemic Chemotherapy and/or Sorafenib
- 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)
This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced Hepatocellular Carcinoma.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brivanib 400 mg, BID | Drug | — | UNRESOLVED |
| Brivanib 800 mg, QD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brivanib 800 mg, QD + BSC
- interventionNames
- Drug: Brivanib 800 mg, QD
- type
- EXPERIMENTAL
- label
- Brivanib 400 mg, BID + BSC
- interventionNames
- Drug: Brivanib 400 mg, BID
Primary outcomes (2)
- measure
- Disease control rate (DCR) at 3 months from randomization
- timeFrame
- 12 weeks from randomization
- description
- Defined as the percentage of patients with complete response, partial response, or stable disease at 12 weeks from randomization by RECIST v1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18-75 years, male or female * Histologically or cytologically confirmed or the clinical diagnosis standard confirmed hepatocellular carcinoma (HCC) patients * Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy * Liver function status Child-Pugh Class A or B (score≤7) * ECOG Performance Status score 0 or 1 * Patients must have adequate bone marrow, renal and hepatic function Exclusion Criteria: * Known history or symptomatic metastatic brain * Uncontrolled moderate and severe ascites * With bleeding tendency and thrombosis history * Known history of severe cardiovascular disease * Uncontrollable active infections (≥CTCAE Grade 2) * Pregnant or breastfeeding women
References
Publications (0)
Data not yet available