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Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

StatusNot Yet Recruiting
PhasePhase 3
Started2024-06-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 30, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2024-04-28
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures v1
Primary completion date2024-11-01→2025-06-30
Completion date2026-11-01→2026-11-30
Start date2023-11-01→2024-06-01
Enrollment target240→360
Study arms2→3
InterventionsSintilimab (Biological), Transarterial Chemoembolization (TACE) (Procedure)→Active surveillance (Other), Sintilimab (18 cycles) (Drug), Sintilimab (9 cycles) (Drug)
Secondary endpoints5 to 4 entries
RFS Rate at 12 ,24 , 36 , 60 Months Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
Primary endpoints1 entry, revised
Recurrence-Free Survival (RFS) at 24 Months
Study description+631 characters
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 [...]
2023-10-17
Original filing
Tongji Hospital
197 trials monitored
See 2 trials at risk
Liver Cancer
1,505 trials monitored
See 60 trials at risk
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.
Trial Details
NCT Number NCT06089369
Lead Sponsor Tongji Hospital
Conditions Hepatocellular Carcinoma
Enrollment 360 participants
Start Date 2024-06-01
Primary Completion 2025-06-30 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2024-04-30