This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.
Age 18-80 years, regardless of gender.
Clinically or pathologically confirmed HCC.
CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.
Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor >5 cm.
Child-Pugh class C liver dysfunction.
Tumor thrombus in the main portal vein or hepatic vein.
Extensive metastatic disease with an expected survival <3 months.
Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).
Single group
Multimodal Thermal Therapy
DeviceThe high-burden tumor is identified as the target lesion for treatment. A pre-treatment biopsy of the target lesion is performed to obtain tumor tissue. Multimodal ablation therapy of the target lesion is conducted under CT guidance. The treatment procedure follows the tumor ablation protocol using the multimodal therapy radiofrequency temperature-controlled mode.
Objective response rate (ORR) according to RECIST 1.1 and mRECIST
Refers to the proportion of patients whose tumors shrink to a certain extent and maintain that response for a specified period, including cases of Complete Response (CR) and Partial Response (PR). Tumor objective response is assessed using RECIST 1.1 and mRECIST criteria. At baseline, subjects must have measurable tumor lesions. According to the efficacy evaluation criteria, the outcomes are classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
Progression-Free Survival（PFS）
It refers to the time from the date of enrollment to the date of the first recorded disease progression(PD)or death,whichever occurs first.
Overall Survival（OS）
Overall Survival(OS)refers to the time from the date of enrollment to the date of death due to any cause.
Safety and Tolerability
Safety:Refers to the extent to which a drug does not cause unacceptable harm or side effects when applied in the human body.Tolerability:Refers to the degree to which patients accept the side effects that occur after treatment,reflecting their ability to endure the side effects of the medication.All adverse events will be recorded and assessed for severity based on the NCI-CTC AE 5.0 grading criteria.During the follow-up period,all subjects will be continuously monitored,and the occurrence,duration,severity,and treatment-relatedness of adverse events will be documented.
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