Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

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 torandomization
• 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, orimmune deficiency
• Known history of serious allergy to any monoclonal antibody or targetedanti-angiogenic drug
• Subjects with inadequately controlled hypertension or history of hypertensive crisisor 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 studytreatment
• Any persistent serious surgery-related complications; esophageal and/or gastricvariceal bleeding within 6 months
• Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6months prior to the start of study treatment
• Inability or refusal to comply with the treatment and monitoring