Clinical Trial

Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer

Not Yet Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07537946
Lead Sponsor Tongji Hospital
Conditions Hepatocellular Carcinoma (HCC), Metastases
Enrollment 400 participants
Start Date 2026-05-30
Primary Completion 2031-05-30 (estimated)
Study Completion 2031-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-17