Clinical Trial

Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT

Recruiting Phase 2
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Summary
This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-25.
Status change: Not Yet Recruiting → Recruiting 2025-04-28
Trial Details
NCT Number NCT06904183
Lead Sponsor Second Affiliated Hospital of Guangzhou Medical University
Collaborators: Affiliated Hospital of Guangdong Medical University, Zhongshan People's Hospital, Guangdong, China, Huizhou Municipal Central Hospital, Jieyang People's Hospital, Guangzhou Development District Hospital, First People's Hospital of Foshan, Anqing Municipal Hospital, Jinan University Affiliated Shunde Hospital
Conditions Hepatocellular Carcinoma Non-resectable
Enrollment 320 participants
Start Date 2025-04-01
Primary Completion 2029-03-31 (estimated)
Study Completion 2030-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11