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NCT04401813 Clinical Trial

Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:
An Open-label, Single-arm, Phase Ib Study of the Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04401813
Other study ID # CIBI310C101
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date June 16, 2020
Est. completion date April 2023

Study information
Verified date October 2022
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 97
Est. completion date April 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IBI308 200mg
Received IBI310 combined with sintilizumab 200mg

Locations
Country Name City State
China Zhongshan Hospital Affiliated to Fudan University Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary adverse event 21-42days
Primary Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma 21-42days
Secondary 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
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