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Ib Study of the Efficacy and Safety of IBI310 Combined With Sintilimab in Advanced Hepatocellular Carcinoma

Ib Study of the Efficacy and Safety of IBI310 Combined With Sintilimab in Advanced Hepatocellular Carcinoma

Recruiting
18-75 years
All
Phase 1

Overview

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

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 details
    Advanced Hepatocellular Carcinoma

NCT04401813

Innovent Biologics (Suzhou) Co. Ltd.

16 February 2024

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