Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach for treating advanced liver cancer (hepatocellular carcinoma, or HCC) that has spread to a few other areas (oligometastasis). The researchers want to see if a combination of methods—using a procedure called ablation to destroy the tumors along with medications called Lenvatinib and a PD-1 inhibitor—can help improve treatment outcomes for patients. Ablation has shown promise for treating some types of cancer spread, but its use in liver cancer with oligometastasis is not well explored yet.

To be eligible for this trial, participants need to have a confirmed diagnosis of primary liver cancer, with only a limited number of metastases (up to five) that are not larger than 5 cm. They should have received Lenvatinib and the PD-1 inhibitor as their main treatment for at least three months before joining the study and must have stable intrahepatic tumors (tumors within the liver). Additionally, participants need to be between 65 and 75 years old, in good overall health, and have a life expectancy of more than three months. If eligible, individuals can expect to contribute to research that may lead to better treatment options for this challenging condition.

Gender

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Eligibility 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.