Combination treatment for large liver cancer with portal vein involvement
Lenvatinib, Sintilimab, and Drug-Eluting Beads Transarterial Chemoembolization With or Without Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma >7 cm With Portal Vein Tumor Thrombus: A Multicenter, Randomized Controlled Trial
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | sintilimab, lenvatinib, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06904183 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with unresectable large hepatocellular carcinoma greater than 7 cm with portal vein tumor thrombosis.
Not a fit: Patients with central nervous system involvement or those who have previously received certain treatments for their cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival and quality of life for patients with advanced liver cancer.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating advanced liver cancer, indicating potential for success in this approach.
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; 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 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.