食管鳞癌新辅助治疗后淋巴结阳性病人行特瑞普利单克隆抗体辅助治疗的多中心、前瞻性、随机对照临床研究设计

Clinical study design of a multicenter, prospective, randomized controlled clinical trial on clinical efficacy of Toripalimab adjuvant therapy on esophageal squamous cell carcinoma patients with post-neoadjuvant positive lymph node staging

摘要: 新辅助治疗已成为局部进展期食管癌首选治疗方式,但行新辅助治疗后淋巴结阳性（ypN+）病人的预后较差,且缺乏有效辅助治疗手段。程序性死亡受体‑1（PD‑1）抗体治疗晚期食管癌可获得较好临床疗效。笔者设计针对行新辅助化疗联合手术切除食管鳞癌病人,接受特瑞普利单克隆抗体（抗PD‑1）辅助治疗的多中心、前瞻性、随机对照临床研究,以期为ypN+病人辅助治疗提供临床实践依据。

Abstract: Neoadjuvant therapy has become the first choice for locally advanced esophageal carcinoma. Patients with post-neoadjuvant positive lymph node staging (ypN+) have poor prognosis, and there is no effective adjuvant therapy. Programmed death protein‑1 (PD‑1) antibody can obtain better clinical efficacy in the treatment of advanced esophageal cancer. The authors designed a multicenter, prospective, randomized controlled clinical trial of Toripalimab (PD-1 antibody) adjuvant therapy on esophageal squamous cell carcinoma patients with ypN+ after the treatment of neoadjuvant chemotherapy combined with surgical resection, in order to provide clinical practices for the adjuvant treatment of ypN+ patients.