Chemotherapy plus camrelizumab versus chemotherapy alone as neoadjuvant treatment for resectable esophageal squamous cell carcinoma (ESCORT-NEO): A multi-center, randomized phase III trial.

作者：Yin Li, Jianjun Qin, Liyan Xue, Anlin Hao, Tao Jiang, Shuoyan Liu, Hongjing Jiang, Mingqiang Kang, Hecheng Li, Hui Tian, Junke Fu, Jianqun Ma, Maoyong Fu, Yongtao Han, Longqi Chen, Lijie Tan, Tianyang Dai, Yongde Liao, Weiguo Zhang, Bin Li · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.3_suppl.lba244 · 被引用次数：15 · 研究领域：Esophageal Cancer Research and Treatment、Cancer Immunotherapy and Biomarkers、Gastric Cancer Management and Outcomes

LBA244 Background: Neoadjuvant chemotherapy or chemoradiotherapy followed by surgery is the standard of care for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC). However, recurrence post-surgery remains a concern. Recent single-arm studies with neoadjuvant camrelizumab plus chemotherapy showed promising results. This multicenter, randomized, open-label, phase III study aims to evaluate the role of neoadjuvant camrelizumab plus chemotherapy followed by adjuvant camrelizumab, versus neoadjuvant chemotherapy alone for resectable LA-ESCC. Methods: Patients with resectable thoracic LA-ESCC (T1b-3N1-3M0 or T3N0M0) were stratified according to clinical stage (I/II, III, or IVa) and randomized (1:1:1) to three groups for two 3-week cycles of neoadjuvant therapy. Group A received camrelizumab, albumin-bound paclitaxel and cisplatin; group B used camrelizumab, paclitaxel and cisplatin; group C received paclitaxel and cisplatin. Surgery was planned 4-6 weeks post-neoadjuvant therapy. Postoperative adjuvant camrelizumab every 3 weeks was given to groups A and B for up to 15 cycles. The co-primary endpoints were pathological complete response (pCR) rate, assessed by an independent blinded pathological committee, and event-free survival, evaluated by investigators per RECIST 1.1. The overall type I error was controlled at a one-sided 0.025 across the primary endpoints using a graphical method. Results: Between April, 2021, and August, 2023, we enrolled 391 patients...