Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
Hepatocellular Carcinoma
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Programmed Cell Death 1, Checkpoint Inhibitor, Immunotherapy, Adjuvant, Hepatocellular Carcinoma, Microvascular Invasion
Eligibility Criteria
Inclusion Criteria: Subjects with a histopathological diagnosis of HCC Undergone a curative resection Pathologically confirmed HCC with microvascular invasion (MVI) Aged 18-75 years No previous systematic treatment and locoregional therapy for HCC prior to randomization Absence of major macrovascular invasion No extrahepatic spread Full recovery from Curative resection within 4 weeks prior to randomization Child-Pugh: Grade A or B(7) ECOG-PS score: 0 or 1 Subjects with HCV- RNA (+) must receive antiviral therapy Adequate organ function Exclusion Criteria: Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC Any preoperative treatment for HCC including local and systemic therapy Have received more than 1 cycle of adjuvant TACE following surgical resection Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy Cardiac clinical symptom or cardiovascular disease that is not well controlled Thrombosis or thromboembolic event within 6 months prior to the start of study treatment Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment Inability or refusal to comply with the treatment and monitoring
Sites / Locations
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sintilimab
TACE(one cycle) + active surveillance