Sintilimab Plus Lenvatinib Phase 3 Trial for Oligo-Extrahepatic Metastatic Hepatocellular Carcinoma
ClinicalTrials.gov Studies
Summary
The NIH ClinicalTrials.gov registry published a Phase 3 study (NCT07537946) evaluating sintilimab plus lenvatinib with or without consolidative therapy in patients with oligo-extrahepatic metastatic hepatocellular carcinoma. The randomized 1:1 trial enrolls participants who achieved disease control after 4 induction cycles. The primary endpoint is overall survival.
What changed
NIH ClinicalTrials.gov registered a new Phase 3 clinical trial (NCT07537946) titled 'Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer.' The study will randomize patients with oligo-extrahepatic metastatic hepatocellular carcinoma who achieved disease control after 4 induction cycles of sintilimab plus lenvatinib to receive either comprehensive local consolidative therapy plus continued systemic therapy or systemic therapy alone. Participants and investigators should review eligibility criteria and enrollment status through ClinicalTrials.gov.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer
Phase 3 NCT07537946 Kind: PHASE3 Apr 17, 2026
Abstract
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.
Conditions: Hepatocellular Carcinoma (HCC), Metastases
Interventions: Sintilimab, Lenvatinib, Comprehensive Local Consolidative Therapy
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