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NCT05616390
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma
Conditions: Hepatocellular Carcinoma
Sex: All
Ages: 20 Years – 79 Years
Phase: PHASE2
Enrollment: 30
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Location: China
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 Criteria:Advanced unresectable hepatocellular carcinoma confirmed by histology or cytologyAge 20-79At least one measurable lesion defined in RECIST version 1.1Child Pugh grade BECOG PS score 2The expected life is at least 90 daysExclusion Criteria:Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or any other treatment that regulates T cellsReceived systemic corticosteroid or immunosuppressive therapy within 28 days before enrollmentComplicated with autoimmune diseases or having a history of chronic or recurrent autoimmune diseasesHistory of pleural or pericardial adhesions within 28 days before enrollmentHIV 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 positiveMultiple 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.
Source: ClinicalTrials.gov (NCT05616390). StuddyBuddy aggregates publicly available trial information.