An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma
Full Title of Study: “An Open-label, Single-arm, Ib Study of the Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: April 2023
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
- Drug: IBI308 200mg
- Received IBI310 combined with sintilizumab 200mg
Arms, Groups and Cohorts
- Experimental: IBI310
- An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma
Clinical Trial Outcome Measures
- adverse event
- Time Frame: 21-42days
- Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma
- Time Frame: 21-42days
- 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).
- Time Frame: 1years
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Provider of Information About this Clinical Study
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