Clinical trial · Interventional
Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma
Donafenib in Advanced Hepatocellular Carcinoma: A Randomized Phase 1B Study of Safety, Efficacy, and Pharmacokinetics
NCT02229071CI-TRIAL-00037752completedPhase 1 / Phase 2ClinicalTrials.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)
This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients wiht advanced hepatocellular carcinoma (HCC) .
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 |
|---|---|---|---|
| Donafenib(200mg) | Drug | — | UNRESOLVED |
| Donafenib(300mg) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Donafenib(200mg)
- description
- Donafenib 200 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
- interventionNames
- Drug: Donafenib(200mg)
- type
- ACTIVE_COMPARATOR
- label
- Donafenib(300mg)
- description
- Donafenib 300 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
- interventionNames
- Drug: Donafenib(300mg)
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18 -70 years old * Patients with measurable, histologically proven, inoperable HCC * Child-Pugh (CP) score of A * Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. * Patients received prior systemic treatments for HCC before 4 weeks * Patients received operate before 3 months * Patients received TACE before 4 weeks * Life expectancy at least 3 months * Adequate hepatic and renal function * Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter) * Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or APTT≤43s;or TT≤21s. Exclusion Criteria: * Patients had prior treatment with sorafenib * CNS involvement.
References
Publications (0)
Data not yet available
No reference posted for this study.