NCT06089369

Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab (9 cycles)	IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 9 cycles）
DRUG	Sintilimab (18 cycles)	IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles）
OTHER	Active surveillance	Active surveillance

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-30
• Completion: 2026-11-30
• First posted: 2023-10-18
• Last updated: 2024-04-30

Locations

1 site across 1 country: China