Background: The AFFINITY trial (NCT05890872) is a prospective, non-randomized, open-label, single-arm study evaluating the safety, immunological impact, and preliminary efficacy of Aliya pulsed electric field ablation in patients with solid tumors. Thirty-one patients were enrolled; thirty received lung lesion ablation prior to continuation on standard-of-care treatment. This manuscript reports six-month local control outcomes and immunological response characteristics. Radiological outcomes were assessed using a modified RECIST 1.1, and immunological impact was evaluated via changes in peripheral blood immunocyte populations and detection of immunoglobulins (Ig) to tumor-associated antigens in serum post-ablation.Methods: Twenty-eight patients underwent radiological assessment of ablated lesions at approximately 1-, 3-, and 6-month post-ablation to evaluate local control. Peripheral blood was collected for immune monitoring using flow cytometry and to detect IgG responses to biopsy-specific and tumor-associated antigens.Results: At 6 months, two cohorts emerged: 12 received ablation only, and 16 received ablation plus systemic and/or focal therapies (radiotherapy or second ablation). In the ablation-only group, imaging showed local control in all ablated lesions (8/12 SD, 4/12 PR), suggesting local efficacy without systemic therapy in those patients. Immunophenotyping showed dynamic changes in circulating immune cells, including T and B cell activation. A subset also exhibited modulation of tumor antigen-specific IgG, indicating a systemic humoral response.Conclusions: This analysis provides preliminary evidence that this form of ablation may promote local tumor control and modulate systemic immune function. These findings support the immunogenic potential of this specialized energy and warrant further investigation. Extended 12-month data for the full cohort will be reported in a future manuscript.
背景：AFFINITY试验（NCT05890872）是一项前瞻性、非随机、开放标签、单臂研究，旨在评估Aliya脉冲电场消融术对实体瘤患者的安全性、免疫学影响及初步疗效。研究共纳入31例患者，其中30例在继续接受标准治疗前接受了肺部病灶消融。本文报告了六个月局部控制结果及免疫应答特征。影像学结果采用改良RECIST 1.1标准评估，免疫学影响通过消融后外周血免疫细胞群变化及血清中肿瘤相关抗原免疫球蛋白（Ig）的检测进行评估。 方法：28例患者在消融后约1、3、6个月接受消融病灶的影像学评估以评价局部控制效果。采集外周血样本，通过流式细胞术进行免疫监测，并检测针对活检特异性抗原及肿瘤相关抗原的IgG应答。 结果：6个月时形成两个队列：12例患者仅接受消融治疗，16例患者接受消融联合全身和/或局部治疗（放疗或二次消融）。在单纯消融组中，影像学显示所有消融病灶均实现局部控制（8/12例疾病稳定，4/12例部分缓解），提示该组患者在未接受全身治疗的情况下获得局部疗效。免疫表型分析显示循环免疫细胞（包括T细胞和B细胞）出现动态活化。部分患者还表现出肿瘤抗原特异性IgG的调节，提示系统性体液免疫应答。 结论：本分析初步证明该消融方式可能促进局部肿瘤控制并调节全身免疫功能。这些发现支持了该特殊能量形式的免疫原性潜力，值得进一步研究。完整队列的12个月延长数据将在后续论文中报告。
肿瘤(癌症)患者之家