Clinical trial · Interventional
Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
NCT04605185CI-TRIAL-00074728unknownPhase 1ClinicalTrials.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 study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable 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 |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib Tosilate Tablets | Drug | — | UNRESOLVED |
| Toripalimab Injection | Biological | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Donafenib/JS001/TACE
- description
- Donafenib and JS001 Combined With TACE
- interventionNames
- Drug: Donafenib Tosilate Tablets
- Biological: Toripalimab Injection
Primary outcomes (1)
- measure
- Dose limiting toxicity(DLT)
- timeFrame
- 21 days after the first dose of JS001 and Donafenib, assessed up to 2 years
- description
- Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity.
Secondary outcomes (3)
- measure
- Overall survival (OS)
- timeFrame
- From the date of randomization until death due to any cause, assessed up to 2 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-75 (inclusive), male or female; * Diagnosis of Unresectable Hepatocellular Carcinoma confirmed clinically or histologically or cytologically according to the "Guidelines for diagnosis and treatment of primary liver cancer" (2019 Edition); * At least one measurable lesion (according to RECIST v1.1) * ECOG performance status score of 0 -1; * Life expectancy ≥ 12 weeks; * Fully understand this research and voluntarily sign the ICF. Exclusion Criteria: * Diffuse liver cancer； * Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome； * Pregnancy or lactation； * Patients with extrahepatic diffusion； * Spontaneous tumor rupture； * Expected non-compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.