Combination treatment for large liver cancer with portal vein involvement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of a combination treatment involving lenvatinib, sintilimab, transarterial chemoembolization with drug-eluting beads (DEB-TACE), and hepatic artery infusion chemotherapy (HAIC) for patients with unresectable large hepatocellular carcinoma (HCC) greater than 7 cm and portal vein tumor thrombosis (PVTT). A total of 320 patients will be randomly assigned to receive either the combination treatment or a standard treatment of lenvatinib, sintilimab, and DEB-TACE. The primary endpoint is time to progression, while secondary endpoints include tumor response, overall survival, and adverse events. The study aims to determine if the addition of HAIC improves outcomes compared to DEB-TACE alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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; prothrombin time prolongation ≤4 seconds
* life expectancy of at least 3 months

Exclusion Criteria:

* 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

Where it's running

• The Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Mingyue Cai, Dr.
• Email: cai020@yeah.net
• Phone: +86-20-34156205

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.