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

Phase 1

Active, not recruiting

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Drug: IBI308 200mg

• Registration Number: NCT04401813
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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

Study Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Study Start: 2020-06-16
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-06
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI310	IBI308 200mg	An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, China