Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma

March 19, 2023 updated by: Tianjin Medical University Cancer Institute and Hospital

A Study to Evaluate the Efficacy and Safety of the Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Child-Pugh B and/or ECOG PS 2 Unresectable Hepatocellular Carcinoma

To evaluate the efficacy and safety of sintilimab combined with bevacizumab and liver protective support therapy in Child-Pugh B and/or ECOG PS 2 unresectable hepatocellular carcinoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

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
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital

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

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced unresectable hepatocellular carcinoma confirmed by histology or cytology
  • Age 20-79
  • At least one measurable lesion defined in RECIST version 1.1
  • Child Pugh grade B
  • ECOG PS score 2
  • The expected life is at least 90 days

Exclusion Criteria:

  • Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or any other treatment that regulates T cells
  • Received systemic corticosteroid or immunosuppressive therapy within 28 days before enrollment
  • Complicated with autoimmune diseases or having a history of chronic or recurrent autoimmune diseases
  • History of pleural or pericardial adhesions within 28 days before enrollment
  • HIV antibody, HTV-Ⅰantibody, HCV antibody, hepatitis B surface protein antigen, hepatitis B surface protein antibody, hepatitis B core protein antibody or any detectable hepatitis B virus DNA test results were positive
  • Multiple primary cancers (excluding completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, and any other cancer that has not recurred for at least 5 years)
  • Brain or meningeal metastasis (unless asymptomatic and does not require treatment)
  • Uncontrollable or serious cardiovascular disease.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy
Drug: Sintilimab
200mg IV d1,Q3W
Other Names:
  • IBI308
Drug: Bevacizumab
7.5mg/kg IV d1,Q3W
Combination product: Liver Protective Support Therapy
Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: Up to 3 years
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Up to 3 years
Overall survival (OS)
Time Frame: Up to 3 years
Defined as the time from the date of treatment start to the date of death
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: Up to 1 years
Defined as proportion of patients who have a best response of CR or PR
Up to 1 years
Disease control rate (DCR)
Time Frame: Up to 1 years
Defined as proportion of patients who have a best response of CR, PR or SD
Up to 1 years
Quality of Life (QoL)
Time Frame: Up to 3 years
The improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)
Up to 3 years

Collaborators and Investigators

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

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)

November 9, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L20220940

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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