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

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

Recruiting
20-79 years
All
Phase 2

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Overview

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

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 details
    Hepatocellular Carcinoma

NCT05616390

Tianjin Medical University Cancer Institute and Hospital

28 January 2024

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