Clinical trial · Interventional
Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma
A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Clinical Study of Toripalimab（JS001） Combined With Donafenib in Patients With Advanced Hepatocellular Carcinoma
NCT04503902CI-TRIAL-00062388HCCunknownPhase 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 study is an open, multi-center phase I/II clinical study.
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 |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib Tosilate Tablets | Drug | — | UNRESOLVED |
| Toripalimab Injection | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JS001+Donafenib
- description
- Donafenib 100mg QD/100 mg BID/200 mg BID orally + JS001 240mg Q3W iv
- interventionNames
- Drug: Donafenib Tosilate Tablets
- Drug: Toripalimab Injection
Primary outcomes (2)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- 28 days after the first dose of JS001 and Donafenib
- description
- Severe toxicity that may be related to JS001 or donafenib during dose escalation of phase I clinical trial
- measure
- Objective response rate（ORR） as determined by the Invertigator using RECIST V1.1
- timeFrame
- From the time of initial administration until intolerant toxicity, disease progression, withdrawal of ICF, loss of follow-up, death or early study termination occurs (whichever occurs first),assessed up to 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with locally advanced or metastatic HCC who are not suitable for surgical resection, who are clinically diagnosed or confirmed by histopathology and/or cytology according to the "Standards for the Diagnosis and Treatment of Primary Liver Cancer" (2017); * At least one measurable lesion (according to RECIST v1.1); * ECOG performance status score of 0 or 1; * Life expectancy ≥ 12 weeks； * Have not received systemic therapy (systemic chemotherapy and/or molecular targeted therapy).If the patient has received adjuvant chemotherapy after local treatment, the chemotherapy needs to be over for more than 12 months, and disease progression or metastasis occurs； * Fully understand this research and voluntarily sign the ICF。 Exclusion Criteria: * Patients with diffuse liver cancer, hepatic encephalopathy that is difficult to control, and liver cancer patients whose lesion size accounts for 70% or more of the entire liver. * Patients with intrahepatic cholangiocarcinoma (ICC) or HCC-ICC mixed type； * Tumor invades inferior vena cava VP4.
References
Publications (0)
Data not yet available
No reference posted for this study.