Clinical trial · Interventional
Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma
Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma: a Controlled,Multicentre,Randomised, Phase 3 Trial
NCT02645981CI-TRIAL-00042671completedPhase 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)
Donafenib versus sorafenib for advanced hepatocellular cancer.
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 | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Donafenib
- description
- Drug:Donafenib; Dose:200mg,bid,po.
- interventionNames
- Drug: Donafenib
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib(Nexavar)
- description
- Drug:Sorafenib; Dose:400mg,bid,po.
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 3 years
- description
- Patient visits are scheduled every 8 weeks to monitor efficacy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Above 18 years old; * Patients with measurable, histologically or clinical proven, inoperable HCC; * Patients wtih measurable lesion and proved by independent radiology committee(IRC); * Child-Pugh (CP) score of 7 or less； * Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; * Patients had not received prior systemic treatments for HCC; * Life expectancy at least 3 months; * Adequate hepatic and renal function; * Adequate hematologic function (platelet count,≥75×109per liter;hemoglobin ≥9.0g per deciliter;neutrophil≥1.5×109per liter,); * Prothrombin time international normal. Exclusion Criteria: * Patients received operate in 3 months; * Patients received transcatheter arterial chemoembolization（TACE） in 4 weeks; * Patients had received systemic therapy; * Patients had prior treatment with sorafenib; * Central nervous system(CNS) involvement; * Severe or mild-degree ascitic fluid; * Main portal vein tumor thrombus; * Inferior venae cava tumor thrombus.
References
Publications (1)
- DERIVEDBi F, Qin S, Gu S, Bai Y, Chen Z, Wang Z, Ying J, Lu Y, Meng Z, Pan H, Yang P, Zhang H, Chen X, Xu A, Cui C, Zhu B, Wu J, Xin X, Wang J, Shan J, Chen J, Zheng Z, Xu L, Wen X, You Z, Ren Z, Xu J, Du C, Fan Q, Zhang L, Tao M, Jiang D, Wang S, Chen Y, Sheng J, Zhuang X, Wu J. Analysis of common treatment-related adverse events of donafenib and its correlation with efficacy: exploratory analysis of the ZGDH3 study. Eur J Med Res. 2025 Oct 29;30(1):1040. doi: 10.1186/s40001-025-03297-6. PMID 41163129