A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection

• Status: Not yet recruiting
• Trial end date: 2026-11-01
• 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) plus Lenvatinib for patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT ) after hepatectomy.

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

Details

• Lead Sponsor: Tongji Hospital
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

• Subjects with a histopathological diagnosis of HCC

• Undergone a curative resection

• Pathologically confirmed HCC with portal vein tumor thrombus (PVTT)

• Aged 18-75 years

• No previous systematic treatment and locoregional therapy for HCC prior to randomization

• 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

• 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

• Active or history of autoimmune disease

• 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