Back to resultsEfficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma
Primary Purpose
Advanced Hepatocellular Carcinoma
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI308 200mg
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Hepatocellular Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Zhongshan Hospital Affiliated to Fudan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IBI310
Arm Description
An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma
Outcomes
Primary Outcome Measures
adverse event
Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma
Secondary Outcome 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).
Full Information
NCT ID
NCT04401813
First Posted
May 6, 2020
Last Updated
October 5, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04401813
Brief Title
Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBI310
Arm Type
Experimental
Arm Description
An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma
Intervention Type
Drug
Intervention Name(s)
IBI308 200mg
Intervention Description
Received IBI310 combined with sintilizumab 200mg
Primary Outcome Measure Information:
Title
adverse event
Time Frame
21-42days
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of IBI310 Combined With Sintilimab in Patients With Advanced Hepatocellular Carcinoma
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