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RECRUITING
NCT06904183
PHASE2

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

Sponsor: Second Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

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).

Official title: Lenvatinib, Sintilimab, and Drug-Eluting Beads Transarterial Chemoembolization With or Without Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma >7 cm With Portal Vein Tumor Thrombus: A Multicenter, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2025-04-01

Completion Date

2030-03-31

Last Updated

2025-04-29

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

LEN+SIN+DEB-TACE+HAIC

For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered. During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE+HAIC.

COMBINATION_PRODUCT

LEN+SIN+DEB-TACE

For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started with 7 days after the first DEB-TACE.

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China