Guo Jincheng, Qiao Chengrui, Lu Jiabin, Yang Shiqing, Zhang Boyi, Tang Dongxia, Pang Hui
Department of Thoracic Surgery, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, China.
Department of Medical Oncology, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, China.
Front Immunol. 2025 Apr 7;16:1486275. doi: 10.3389/fimmu.2025.1486275. eCollection 2025.
Combination of anti-PD-1 monoclonal antibody with chemotherapy has been widely used as a first-line treatment for metastatic esophageal squamous cell carcinoma (ESCC). However, the efficacy of this therapeutic combination as a neoadjuvant intervention for resectable ESCC remains inadequately explored. This study aims to evaluate the efficacy and safety of sintilimab in combination with chemotherapy as a neoadjuvant therapy for ESCC.
In this single-arm, phase II study, patients with histopathologically diagnosed resectable ESCC who had clinical cT1-3/N0-1M0 (stage II-III) were recruited. Sintilimab (200mg, iv, d1) in combined with chemotherapy (nab-paclitaxel 260 mg/m, d1 and cisplatin 75 mg/m, d1-3) were administered every 3 weeks for 2 cycles. The primary endpoint was pathological complete response (pCR).
From November 2020 through November 2022, 29 patients were enrolled and 27 completed the two cycles of neoadjuvant therapy. A total of 21 patients underwent surgery. The pCR rate was 28.6% (6/21) and the major pathologic response (MPR) rate was 42.9% (9/21). The most common Grade 3 or 4 treatment-related adverse events were leukopenia (26.7%) and neutropenia (20%). No delays in surgical procedures or unexpected surgical complications attributable to the treatment were reported.
The combination of sintilimab and chemotherapy as a neoadjuvant regimen was tolerable and associated with favorable responses for ESCC patients. Given these favorable results, this regimen could serve as a viable alternative in the neoadjuvant treatment landscape for ESCC, with particular applicability to Chinese patient populations.
https://www.chictr.org.cn/, identifier ChiCTR2000040345.
抗程序性死亡蛋白1（PD-1）单克隆抗体与化疗联合已被广泛用作转移性食管鳞状细胞癌（ESCC）的一线治疗方法。然而，这种治疗组合作为可切除ESCC新辅助干预措施的疗效仍未得到充分探索。本研究旨在评估信迪利单抗联合化疗作为ESCC新辅助治疗的疗效和安全性。
在这项单臂II期研究中，招募了组织病理学诊断为可切除ESCC且临床分期为cT1-3/N0-1M0（II-III期）的患者。信迪利单抗（200mg，静脉注射，第1天）联合化疗（白蛋白结合型紫杉醇260mg/m²，第1天和顺铂75mg/m²，第1-3天）每3周给药1次，共2个周期。主要终点为病理完全缓解（pCR）。
从2020年11月至2022年11月，共纳入29例患者，27例完成了两个周期的新辅助治疗。共有21例患者接受了手术。pCR率为28.6%（6/21），主要病理缓解（MPR）率为42.9%（9/21）。最常见的3级或4级治疗相关不良事件为白细胞减少（26.7%）和中性粒细胞减少（20%）。未报告因治疗导致的手术延迟或意外手术并发症。
信迪利单抗与化疗联合作为新辅助方案耐受性良好，对ESCC患者有良好反应。鉴于这些良好结果，该方案可作为ESCC新辅助治疗的一种可行选择，尤其适用于中国患者群体。
