Workflow for HIFU treatment of liver metastases.

Purpose
Given the unique features of the liver, it is necessary to combine immunotherapy with other therapies to improve its efficacy in patients of advanced cancer with liver metastases (LM). High-intensity focused ultrasound (HIFU) ablation is now widely used in clinical practice and can enhanced immune benefits. The study is intended to prospectively evaluate the safety and clinical feasibility of HIFU ablation in combination with systemic immunotherapy for patients with liver metastases.
Methods
The study enrolled 14 patients with LM who received ultrasound-guided HIFU ablation combined with immune checkpoint inhibitors (ICIs) such as anti-programmed cell death protein 1 (anti-PD-1 agents manufactured in China) at Mianyang Central Hospital. Patients were followed up for adverse events (AEs) during the trial, using the CommonTerminology Criteria for Adverse Events v5.0(CTCAE v5.0) as the standard. Tumour response after treatment was assessed using computerized tomography.
Results
The 14 patients (age range, 35–84 years) underwent HIFU ablation at 19 metastatic sites and systemic immunotherapy. The mean lesion volume was 179.9 cm3 (maximum: 733.1 cm3). Median follow-up for this trial was 9 months (range: 3–21) months. The study is clinically feasible and acceptable to patients.
Conclusion
This prospective study confirmed that HIFU combined with immunotherapy is clinically feasible and safe for treating liver metastases.

研究目的：
鉴于肝脏的独特生理与解剖特性，为提升晚期肝转移瘤（liver metastases, LM）患者的免疫治疗疗效，需将免疫治疗与其他治疗手段联合应用。高强度聚焦超声（high-intensity focused ultrasound, HIFU）消融目前已在临床广泛应用，且可增强免疫获益。本研究旨在前瞻性评估HIFU消融联合全身免疫治疗用于肝转移瘤患者的安全性与临床可行性。

研究方法：
本研究纳入绵阳市中心医院收治的14例肝转移瘤患者，所有患者均接受超声引导下HIFU消融联合免疫检查点抑制剂（immune checkpoint inhibitors, ICIs）治疗，其中包括国产抗程序性死亡蛋白1（anti-programmed cell death protein 1, anti-PD-1）制剂。试验期间采用不良事件通用术语标准5.0版（CommonTerminology Criteria for Adverse Events v5.0, CTCAE v5.0）作为评估标准，对患者的不良事件（adverse events, AEs）进行随访监测。治疗后的肿瘤应答情况通过计算机断层扫描（computerized tomography, CT）进行评估。

研究结果：
本研究纳入的14例患者年龄范围为35~84岁，共计在19个转移灶部位实施了HIFU消融联合全身免疫治疗。患者的平均病灶体积为179.9 cm³（最大体积为733.1 cm³）。本试验的中位随访时间为9个月（范围3~21个月）。结果显示，该治疗方案临床可行且患者耐受性良好。

研究结论：
本前瞻性研究证实，HIFU联合免疫治疗用于肝转移瘤的治疗具有临床可行性与安全性。