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

Recruiting now · Phase 3

Conditions studied: Hepatocellular Carcinoma Non-resectable

In brief

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).

Key facts

Study ID

NCT06492395

Run by

Second Affiliated Hospital of Guangzhou Medical University

People needed

178

Starts

2024-08-01

Expected to finish

2027-07-31

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• a confirmed diagnosis of HCC
• the largest intrahepatic lesion >7 cm
• presence of PVTT on imaging
• tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
• Eastern Cooperative Oncology Group performance status ≤1
• Child-Pugh class A/B
• adequate hematologic and organ function, with leukocyte count>3.0×10\^9/L, neutrophil count>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal
• life expectancy of at least 3 months

You may not qualify if…

• Diffuse HCC
• accompanied with vena cava tumor thrombus
• central nervous system involvement
• previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
• organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
• history of other malignancies
• uncontrollable infection
• history of HIV
• history of organ or cells transplantation
• prothrombin time prolongation >4 s

Where it is running

• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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