Clinical trial
Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
Name
JS001D-C-103
Description
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.
Trial arms
Trial start
2021-01-08
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Donafenib Tosilate Tablets
100mg Qd/150mg Qd/100mg Bid, po
Arms:
Donafenib/JS001/TACE
Toripalimab Injection
240 mg, iv drip,q3w
Arms:
Donafenib/JS001/TACE
Other names:
JS001
Size
18
Primary endpoint
Dose limiting toxicity(DLT)
21 days after the first dose of JS001 and Donafenib, assessed up to 2 years
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}
Updated at
2024-03-06
1 organization
3 products
1 indication
Organization
Suzhou Zelgen BiopharmaceuticalsProduct
DonafenibIndication
Hepatocellular CarcinomaProduct
ToripalimabProduct
Donafenib Tosilate