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

Tianjin Medical University

Status and phase

Enrolling

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Sintilimab

Drug: Bevacizumab

Combination Product: Liver Protective Support Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05616390

L20220940

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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.