Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

• Status: Not yet recruiting
• Trial end date: 2026-11-30
• Target enrollment: 0
• Participant gender: All

Summary

To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tongji Hospital

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