Treatment of Advanced Hepatocellular Carcinoma with Ablation of Oligometastases Combined with Lenvatinib and PD-1 Inhibitor in a Multicenter Phase II Study

What this Trial Is About

Researchers are investigating the use of ablation combined with lenvatinib and a PD-1 inhibitor for advanced hepatocellular carcinoma HCC with oligometastasis. This study explores a subtype of metastatic HCC where there are limited metastases, aiming to evaluate whether removing these metastases can improve survival. The trial is a multicenter, prospective, phase II study focused on the safety and effectiveness of this combined approach. Participants receive a treatment combining ablation of oligometastases using microwave ablation, radiofrequency ablation, or cryoablation, along with systemic therapy using lenvatinib and PD-1 inhibitors. Ablation targets metastases limited to five sites in no more than two organs, each measuring up to 5 cm. Patients must have already received at least 3 months of lenvatinib and PD-1 inhibitor therapy with controlled intrahepatic tumors before ablation. Throughout the study, participants will be monitored for progression-free survival over 24 months as the primary outcome. Additional assessments include overall survival, objective response rate, and adverse events within 12 to 24 months. Researchers will perform regular evaluations to track treatment response and safety, with the total study duration extending to August 2027.

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