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

Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05616390
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events (AEs) [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

    2. Overall survival (OS) [Up to 3 years]

      Defined as the time from the date of treatment start to the date of death

    Secondary Outcome Measures

    1. Overall response rate (ORR) [Up to 1 years]

      Defined as proportion of patients who have a best response of CR or PR

    2. Disease control rate (DCR) [Up to 1 years]

      Defined as proportion of patients who have a best response of CR, PR or SD

    3. Quality of Life (QoL) [Up to 3 years]

      The improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin China 300060

    Sponsors and Collaborators

    • Tianjin Medical University Cancer Institute and Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianjin Medical University Cancer Institute and Hospital
    ClinicalTrials.gov Identifier:
    NCT05616390
    Other Study ID Numbers:
    • L20220940
    First Posted:
    Nov 15, 2022
    Last Update Posted:
    Nov 15, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tianjin Medical University Cancer Institute and Hospital
    Hepatocellular Carcinoma
    Sintilimab
    Bevacizumab
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Bevacizumab

    Study Results

    No Results Posted as of Nov 15, 2022