Status:
COMPLETED
Efficacy and Safety of IBI310 Combined with Sintilimab in Patients with Advanced Hepatocellular Carcinoma
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- inclusion criteria：
- Locally advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology.
- Disease progression after surgery and / or local treatment.
- Previous standard systemic treatments for advanced hepatocellular carcinoma have failed or developed intolerable toxicity.
- exclusion criteria：
- Histology contains fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
- Have a history of hepatic encephalopathy, or have a history of liver transplantation.
- Diffuse liver cancer.
Exclusion
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04401813
Start Date
June 16 2020
End Date
June 21 2024
Last Update
September 19 2024
Active Locations (1)
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1
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China