Ablation combined with lenvatinib and PD-1 inhibitor for advanced liver cancer with limited metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.