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

Overview

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

Full Title of Study: “An Open-label, Single-arm, Ib Study of the Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2023

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

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • adverse event
    • Time Frame: 21-42days
  • Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma
    • Time Frame: 21-42days

Secondary Measures

  • 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).
    • Time Frame: 1years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Innovent Biologics (Suzhou) Co. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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