drugset / Trial / NCT07537946

Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer

NCT07537946

Phase 3 Not yet recruiting 400 enrolled Tongji Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

This study evaluates whether comprehensive local consolidative therapy added to continued sintilimab plus lenvatinib improves survival compared with continued sintilimab plus lenvatinib alone in patients with oligo-extrahepatic metastatic hepatocellular carcinoma. All enrolled participants receive induction treatment with sintilimab plus lenvatinib for 4 cycles. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for complete consolidation are randomized in a 1:1 ratio to receive either comprehensive local consolidative therapy followed by continued systemic therapy or continued systemic therapy alone. The primary outcome is overall survival.

Timeline

Start
2026-05-30
Primary completion
2031-05-30
Completion
2031-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Sintilimab Monoclonal antibody 200 mg Intravenous