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

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Drug: IBI308 200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04401813

CIBI310C101

Details and patient eligibility

About

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

Full 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

Enrollment: 97 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

IBI310

Experimental group

Description:

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

Treatment:

Drug: IBI308 200mg