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Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT

NCT06492395 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2025-01-29

No results posted yet for this study

Summary

This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).

Conditions

  • Hepatocellular Carcinoma Non-resectable

Interventions

COMBINATION_PRODUCT

Len+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 will be started with 7 days after the first DEB-TACE+HAIC.

COMBINATION_PRODUCT

Len+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 will be started with 7 days after the first DEB-TACE+HAIC.

Sponsors & Collaborators

  • Second Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06492395 on ClinicalTrials.gov