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

Last updated: March 19, 2023
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Cancer

Liver Disease

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05616390
L20220940
  • Ages 20-79
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or anyother treatment that regulates T cells
  • Received systemic corticosteroid or immunosuppressive therapy within 28 days beforeenrollment
  • Complicated with autoimmune diseases or having a history of chronic or recurrentautoimmune 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 anydetectable hepatitis B virus DNA test results were positive
  • Multiple primary cancers (excluding completely resected basal cell carcinoma, stage Isquamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficialbladder 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 Design

Total Participants: 30
Study Start date:
November 09, 2022
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

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