Advanced Hepatocellular Carcinoma
Conditions
Brief summary
An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma
Detailed description
In this study, approximately 18 to 47 patients who have previously received sorafenib, lenvatinib, or oxaliplatin-containing chemotherapy . After determining the dose of IBI310, the study will enter the expansion phase
Interventions
DRUGIBI308 200mg
Received IBI310 combined with sintilizumab 200mg
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
： 1. Locally advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology. 2. Disease progression after surgery and / or local treatment. 3. Previous standard systemic treatments for advanced hepatocellular carcinoma have failed or developed intolerable toxicity.
Exclusion criteria
： 1. Histology contains fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components. 2. Have a history of hepatic encephalopathy, or have a history of liver transplantation. 3. Diffuse liver cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event | 21-42days |
| Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma | 21-42days |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the ORR of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma (researched by the investigator according to RECIST V1.1). | 1years |
Countries
China
Outcome results
None listed