Combining lenvatinib with TACE and HAIC for large liver cancer with portal vein thrombosis
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
This study is testing a new combination treatment for people with large liver cancer and blood clots in the portal vein to see if it works better than just one of the treatments alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | lenvatinib, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06492395 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a combination treatment involving lenvatinib, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE), and hepatic artery infusion chemotherapy (HAIC) in patients with large hepatocellular carcinoma (HCC) greater than 7 cm and portal vein tumor thrombosis (PVTT). The study is multicenter, prospective, and randomized, enrolling 178 patients who will be assigned to either the combination treatment or lenvatinib plus DEB-TACE alone. The primary endpoint is time to progression, while secondary endpoints include tumor response, overall survival, and adverse events. Treatments can be repeated based on follow-up evaluations by a multidisciplinary team.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with unresectable large HCC greater than 7 cm with confirmed PVTT.
Not a fit: Patients with diffuse HCC or those with central nervous system involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with large HCC and PVTT.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating HCC with combined therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * life expectancy of at least 3 months Exclusion Criteria: * 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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.