Comparing TACE-Lenvatinib with TACE-Lenvatinib-ablation for recurrent liver cancer
The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma: a Multicenter Randomized Control Study
This study is testing if adding ablation to the combination of TACE and Lenvatinib can help people with recurrent liver cancer feel better compared to just using TACE and Lenvatinib alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Lenvatinib |
| Locations | 1 site (Beijing, None Selected) |
| Trial ID | NCT06609850 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining transarterial chemoembolization (TACE) with Lenvatinib and ablation techniques for patients with intermediate recurrent hepatocellular carcinoma (RHCC). It aims to determine if the addition of ablation improves patient outcomes compared to TACE and Lenvatinib alone. The study will involve patients diagnosed with intermediate-stage RHCC, focusing on those who have not shown tumor progression after initial TACE treatment. By identifying the most responsive patients, the study seeks to enhance treatment strategies for this heterogeneous condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with intermediate-stage recurrent hepatocellular carcinoma and specific tumor characteristics.
Not a fit: Patients with primary intermediate-stage HCC, extrahepatic metastasis, or those with tumors larger than 5 cm may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and treatment outcomes for patients with intermediate recurrent hepatocellular carcinoma.
How similar studies have performed: While studies have shown the benefits of TACE combined with Lenvatinib, the specific combination with ablation for intermediate RHCC is still being explored and lacks extensive prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-75 years; 2. RHCC diagnosed by imaging; 3. intermediate-stage RHCC (two to three lesions which at least one was \>3 cm in size or more than three tumors); 4. the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm; 5. absence of extrahepatic metastasis or macrovascular invasion; 6. Child-Pugh class A or B; 7. TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE. 8. life expectance \>3 months; Exclusion Criteria: 1. under 18 years or over 75 years of age; 2. primary intermediate-stage HCC; 3. RHCC with more than six tumors, or single RHCC (5) RHCC \>5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;
Where this trial is running
Beijing, None Selected
- Chinese PLA General hospital — Beijing, None Selected, China (Recruiting)
Study contacts
- Study coordinator: Qunfang Zhou
- Email: zhouqun988509@163.com
- Phone: 86 19868000115
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.