术前化疗（CT）或放化疗（CRT）显示局部晚期食管鳞状细胞癌（ESCC）患者的生存获益；然而，食管鳞癌患者的预后仍然不佳。我们进行了两项 II 期单臂临床试验，以评估术前 CT 或 CRT 与新辅助程序性细胞死亡蛋白 1 (PD-1) 抑制剂联合治疗食管癌的潜在益处、有效性、可行性和安全性.患者纳入来自两项 II 期单臂试验（NCT04506138 和 NCT03940001）且经组织学证实的 ESCC（根据美国癌症联合委员会第 8 分期系统的临床 II-IVA 期）的患者。患者每 3 周接受两剂静脉注射 PD-1 抑制剂（卡瑞利珠单抗或信迪利单抗），并结合两个周期的 CT 或 CRT。该研究的主要终点是食管切除术的安全性和短期结果，以术前 PD-1 抑制剂与 CT 或 CRT 联合使用后 30 天内发生并发症的风险来衡量。次要终点是评估 pCR 率（ pT0N0)、两组间原发肿瘤 pCR 率 (pT0)、手术时间、术后停留时间和 30 天死亡率。使用多变量对数二项式回归模型比较两组之间的结果，以获得调整后的相对风险比（RR）。2019年5月至2022年6月期间，纳入了55名患者。所有患者均完成新辅助治疗。两组的年龄、性别、体能状态、临床分期、组织学亚型、手术类型、手术时间和失血量相似。 nICRT组原发肿瘤pCR率为52.9%，nICT组为21.6%（P=0.03）；nICRT组术后pCR率为41.2%，nICT组为21.6%（P=0.19）。 nICT组的微创手术率为89.2%（33/37），nICRT组的微创手术率为94.1%（16/17）。两组发生肺部、吻合口或其他并发症的风险相似。食管癌新辅助治疗中术前 CT 或 CRT 中添加 PD-1 抑制剂后食管切除术是安全的。后续行动和探索性终点（包括生物标志物分析）正在进行中。2024 年胃肠肿瘤学杂志。版权所有。

Preoperative chemotherapy (CT) or chemoradiotherapy (CRT) show survival benefits in patients with locally advanced esophageal squamous cell carcinoma (ESCC); however, ESCC patients still have a dismal prognosis. We conducted two phase-II, single-armed clinical trials to assess the potential benefits, efficacy, feasibility, and safety of esophagectomy after combining preoperative CT or CRT and neoadjuvant programmed cell death protein 1 (PD-1) inhibitors in the treatment of ESCC.Patients were included with histologically confirmed ESCC (clinical stage II-IVA according to the American Joint Committee on Cancer 8th staging system) from two phase-II, single-arm trials (NCT04506138 and NCT03940001). Patients underwent two doses of intravenous PD-1 inhibitor (either camrelizumab or sintilimab) every 3 weeks, combined with two cycles of either CT or CRT. The primary endpoint of the study was the safety and short-term outcomes of esophagectomy as measured by the risk of developing complications within 30 days, after the combination of preoperative PD-1 inhibitor and CT or CRT Secondary endpoint was to evaluate the pCR rates (pT0N0), primary tumor pCR rates (pT0), operation time, postoperative stay, and 30-day mortality rate between both groups. Results between both groups were compared using a multivariable log-binomial regression model to obtain the adjusted relative risk ratios (RRs).Between May 2019 and June 2022, 55 patients were included. All patients completed neoadjuvant therapy. Age, sex, performance status, clinical stage, histologic subtype, procedure type, operative time, and blood loss volume were similar between the two groups. The primary tumor pCR rates were 52.9% in the nICRT group and 21.6% in the nICT group (P=0.03), while the postoperative pCR rates were 41.2% in the nICRT group and 21.6% in the nICT group (P=0.19). The minimally invasive surgery rates were 89.2% (33/37) in the nICT group and 94.1% (16/17) in the nICRT group. The risk of developing pulmonary, anastomotic, or other complications were similar between the two groups.Esophagectomy was safe after the addition of the PD-1 inhibitor to preoperative CT or CRT in ESCC neoadjuvant therapies. Follow-up and the exploratory endpoints, including biomarkers analyses, are ongoing.2024 Journal of Gastrointestinal Oncology. All rights reserved.