drugset / Trial / NCT07537946
Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Lenvatinib | Small molecule | 12 mg | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |