Combining TACE/HAIC with Lenvatinib and Sintilimab for Liver Cancer Treatment
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Patients With Potentially High Recurrence Risk After Liver Cancer Resection: a Prospective, Randomized, Controlled Clinical Study
This study is testing a new combination treatment for patients with intermediate-stage liver cancer to see if it can lower the chances of cancer coming back after surgery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, sintilimab, lenvatinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05250843 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining transarterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) with lenvatinib and sintilimab as a neoadjuvant therapy for patients with intermediate-stage hepatocellular carcinoma (HCC) prior to liver resection. The goal is to reduce the recurrence of cancer in high-risk patients by enhancing the local delivery of chemotherapy and utilizing immune checkpoint inhibitors. The study will involve a randomized control design to compare this combination therapy against direct surgical treatment. Patients will be monitored for treatment efficacy and safety throughout the process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with intermediate-stage hepatocellular carcinoma who have not received prior anti-HCC treatment.
Not a fit: Patients with advanced disease characterized by definite tumor thrombus or distant metastasis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence rates of hepatocellular carcinoma after surgery, improving long-term survival for patients.
How similar studies have performed: While TACE and HAIC have been used separately in various studies, the combination with lenvatinib and sintilimab in this specific context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1) Age 18-70 years old, gender is not limited. * 2)The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL). * 3)Patients must have at least one tumor lesion that can be accurately measured. * 4)Conform to any of the following criteria (1) multiple nodules \>3; (2) ≥2 nodules, any of which is \>3 cm; (3) invasion of the portal vein or hepatic vein. * 5)According to the 2022 edition of the Chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group * 6)No previous anti-HCC treatment. * 7)Eastern Co-operative Group performance status 2 or less. * 8)Liver function: Child's A or B (score \< 7). Exclusion Criteria: * 1)Patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava; * 2) Allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs; * 3) Local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months
Where this trial is running
Guangzhou, Guangdong
- Third Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
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.