Ablation combined with lenvatinib and PD-1 inhibitor for advanced liver cancer with limited metastases
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma: A Multicenter, Prospective, Phase II Study
This study is testing if combining a targeted treatment with a special type of therapy can help people with advanced liver cancer that has spread a little, to see if it improves their chances of living longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Lenvatinib, chemotherapy |
| Locations | 1 site (Beijing, None Selected) |
| Trial ID | NCT06550921 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of combining image-guided ablation therapy with lenvatinib and a PD-1 inhibitor for patients with advanced hepatocellular carcinoma (HCC) that has limited metastases, known as oligometastasis. The approach aims to eliminate these metastases, which may improve patient prognosis. The study is multicenter and single-arm, focusing on patients who have undergone prior systemic therapy and locoregional treatments. The goal is to evaluate the survival benefits of this combined treatment strategy.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with primary HCC who have oligometastasis and have received lenvatinib and PD-1 inhibitor therapy for at least three months.
Not a fit: Patients with widespread metastases beyond the defined oligometastatic criteria or those with uncontrolled intrahepatic tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival outcomes for patients with advanced HCC and oligometastasis.
How similar studies have performed: While the combination of ablation with systemic therapies has shown promise in other cancers, this specific approach for advanced HCC with oligometastasis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases 20; 2. presence of oligometastasis, the metastases found within three month of HCC diagnosis; 3. metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm; 4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy for a minimum of 3 months before study ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST); 5. undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC); 6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. no history of other malignancies. 8. life expectancy more than 3 months; 9. agreed to participated in this clinical trial; 10. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min. Exclusion Criteria: 1. recurrent HCC; 2. advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy; 3. age \< 18 years or \> 75 years; 4. advanced HCC with more than five metastases; 5. no response to Lenvatinib; 6. metastases size \> 5 cm; 7. life expectancy less than 3 months.
Where this trial is running
Beijing, None Selected
- Chinese PLA General hospital — Beijing, None Selected, China (Recruiting)
Study contacts
- Principal investigator: Feng Duan, MD — Chinese PLA General Hospital
- Study coordinator: Qunfang Zhou, MD
- 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.