RecruitingPhase 3NCT06492395

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

A Multicentre, Randomised Controlled Study of Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy With FOLFOX Regimen Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma Larger Than 7 cm With Portal Vein Tumor Thrombosis

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

178 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Non-resectable

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for people with large liver cancer (hepatocellular carcinoma, HCC, larger than 7 cm) with tumor invasion into the portal vein (a major blood vessel in the liver). One group receives lenvatinib (a targeted therapy tablet) plus DEB-TACE (a chemoembolization procedure) and HAIC (chemotherapy infused directly into the liver artery), while the other receives lenvatinib plus DEB-TACE alone. **You may be eligible if...** - You have confirmed liver cancer (HCC) with the largest tumor larger than 7 cm - You have portal vein tumor invasion visible on imaging - Your liver function is relatively preserved (Child-Pugh A or B) - Your overall health is adequate (ECOG 0–1) **You may NOT be eligible if...** - You have diffuse HCC (cancer spread throughout the liver in a widespread pattern) - Your cancer has also invaded the inferior vena cava (a large vein near the heart) - You have significant organ failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTLen+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_PRODUCTLen+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.