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

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Bevacizumab

Criteria

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.