本研究报告了针对最初不可切除的晚期食管鳞状细胞癌 (ESCC) 患者进行诱导免疫化疗的 2 期、开放标签、单组、探索性临床试验的安全性和有效性。患者接受了 tislelizumab 的三个周期的诱导治疗，顺铂和5-氟尿嘧啶。主要终点是安全性、主要病理反应（MPR）和病理完全反应（pCR）。次要终点包括 R0 切除率、无病生存期 (DFS) 和总生存期 (OS)。对基因组数据和免疫微环境数据进行了探索性分析。治疗安全，3级及以上不良事件发生率为14.9%（7/47）。在参与该研究的总共 47 名患者中，19 名（40.4%）实现 MPR，12 名（25.5%）实现 pCR，4 名（8.5%）实现完全临床缓解（cCR）并拒绝手术，23 名（48.94%）获得成功切除。中位随访时间为 18 个月，中位 DFS 为 24 个月，中位 OS 为 36 个月。高肿瘤突变负荷与接受手术的患者更好的预后相关。与经历重大病理反应的患者相比，达到pCR的患者免疫细胞浸润水平更高，三级淋巴结构比例和浓度更高。替雷利珠单抗联合化疗对ESCC有效，获得高cCR、pCR、手术转化和R0 切除率和可耐受的不良事件。NCT05469061.© 2024。外科肿瘤学会。

This study reported the safety and efficacy of a phase 2, open-label, single-arm, exploratory clinical trial of induction immunochemotherapy in patients with initially unresectable advanced esophageal squamous cell carcinoma (ESCC).Patients underwent three cycles of induction therapy with tislelizumab, cisplatin, and 5-fluorouracil. The primary endpoints were the safety, major pathological response (MPR), and pathological complete response (pCR). Secondary endpoints included the R0 resection rate, disease-free survival (DFS), and overall survival (OS). Genomic data and immune microenvironment data were analyzed exploratively.The treatment was safe, with a grade 3 or higher adverse event rate of 14.9% (7/47). Of the total 47 patients enrolled in the study, 19 (40.4%) achieved MPR, 12 (25.5%) achieved pCR, 4 (8.5%) achieved complete clinical response (cCR) and declined surgery, and 23 (48.94%) underwent successful resection. Median follow-up was 18 months, with a median DFS of 24 months, a median OS of 36 months. A high tumor mutation burden was associated with a better prognosis for patients who underwent surgery. Patients who achieved pCR had higher levels of immune cell infiltration and a greater proportion and concentration of tertiary lymphoid structures compared with those who experienced a major pathological response.Tislelizumab combined with chemotherapy is effective for ESCC, yielding high cCR, pCR, surgical conversion, and R0 resection rates, and tolerable adverse events.NCT05469061.© 2024. Society of Surgical Oncology.