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Completed

NCT Number: NCT04401813

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

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

Completed

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Key information

Conditions

Advanced Hepatocellular Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

：

  • Locally advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology.
  • Disease progression after surgery and / or local treatment.
  • Previous standard systemic treatments for advanced hepatocellular carcinoma have failed or developed intolerable toxicity.

Exclusion criteria

：

  • Histology contains fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
  • Have a history of hepatic encephalopathy, or have a history of liver transplantation.
  • Diffuse liver cancer.

Treatment and study plan

IBI308 200mg

Drug

Received IBI310 combined with sintilizumab 200mg

Primary outcomes

  1. adverse event

    Time frame: 21-42days

  2. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 26, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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