Combining lenvatinib with TACE and HAIC for large liver cancer with portal vein thrombosis
Official title: 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
Run by Second Affiliated Hospital of Guangzhou Medical University · NCT06492395 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 178 (estimated) |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | lenvatinib, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | July 31, 2026 |
| Study ends | July 31, 2027 |
| Registry record updated | January 29, 2025 |
| Trial ID | NCT06492395 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with unresectable large HCC greater than 7 cm with confirmed PVTT.
✕Probably not a fit
Patients with diffuse HCC or those with central nervous system involvement may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with large HCC and PVTT.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in treating HCC with combined therapies.
Who can join: the full rules
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 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Combining Lenvatinib with SIRT for Advanced Liver Cancer
This study is testing whether combining a cancer drug called lenvatinib with a type of radiation therapy can help people with advanced liver cancer that hasn't improved with other treatments.
-
Combination treatment for large liver cancer with portal vein involvement
This study is testing a new combination treatment for people with large liver cancer that has spread to the portal vein to see if it works better than the standard treatment.
-
Triple therapy for patients with unresectable liver cancer
This study is testing a new combination treatment for patients with hard-to-treat liver cancer to see if it can help shrink tumors more and improve survival rates.
-
Combination therapy for advanced liver cancer
This study is testing a new combination of treatments for advanced liver cancer to see if it can shrink tumors enough to make them operable.
-
Comparing two treatment combinations for advanced liver cancer
This study is testing two different treatment combinations for advanced liver cancer to see which one helps patients live longer after their first round of a specific procedure.
-
Combining lenvatinib with iodine-125 seed brachytherapy for treating liver cancer
This study is testing if combining a medication called lenvatinib with a special type of radiation therapy can help people with liver cancer that hasn't improved with other treatments live longer and feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.