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

October 5, 2022 updated by: Innovent Biologics (Suzhou) Co. Ltd.

An Open-label, Single-arm, Phase Ib Study of the 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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Zhongshan Hospital affiliated to Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: IBI308 200mg
Received IBI310 combined with sintilizumab 200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adverse event
Time Frame: 21-42days
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
21-42days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 16, 2020

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (ACTUAL)

May 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI310C101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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