Study of Multimodal Ablation Combined With Tislelizumab, Lenvatinib, and TACE for Treating Unresectable Primary Liver Cancer

What this Trial Is About

Researchers are evaluating a treatment approach for patients with unresectable primary liver cancer, specifically hepatocellular carcinoma HCC. This prospective, single-arm, single-center trial investigates the combination of transarterial chemoembolization TACE, multimodal thermal ablation, and systemic therapies including the PD-1 monoclonal antibody Tislelizumab and the drug lenvatinib. The study aims to assess the effectiveness and safety of this combined treatment and to better understand immune changes before and after therapy in managing primary liver cancer. Participants will begin with induction therapy using Tislelizumab and lenvatinib within 14 days of enrollment. Between 2 and 7 days later, they will undergo multimodal thermal therapy MTT guided by CT scans, targeting the main tumor. After MTT, on-demand TACE treatment will be given as needed. From 7 days post-MTT, patients will resume Tislelizumab and lenvatinib treatment until disease progression, intolerable side effects, or withdrawal from the study. Throughout the 12-month follow-up, participants will have regular assessments to monitor tumor response using imaging criteria RECIST 1.1 and mRECIST at intervals from 2 weeks to 12 months after treatment. Researchers will also evaluate progression-free survival, overall survival, and safety at scheduled visits every 3 months. This monitoring includes clinical evaluations, immune marker comparisons before and after treatment, and tolerability checks to understand the clinical benefit and risks of this combined therapy approach.

Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study