Zheng Yan, Liu Xian-Ben, Sun Hai-Bo, Xu Jinliang, Shen Sining, Ba Yu-Feng, Yan Ming, Qin Zimin, Liu Bao-Xing, Wang Zong-Fei, Liu Shi-Lei, Zhang Rui-Xiang, Chen Pei-Nan, Liang Guang-Hui, Yuan Dongfeng, Li Zhen-Xuan, Liu Qi, Wang Hao-Ran, Li Hao-Miao, Lv Hongwei, Ma Xiaochao, Zhu Jianping, Yu Yong-Kui, Xing Wen-Qun
Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Ann Transl Med. 2021 Jan;9(1):73. doi: 10.21037/atm-20-5404.
Neoadjuvant chemotherapy (NAC) and neoadjuvant chemoradiotherapy (NACR) are the standard treatments for esophageal squamous cell carcinoma (ESCC). However, the 5-year overall survival (OS) rate is still far from satisfactory. In recent years, immune checkpoint inhibitors (ICIs) have shown promising results in the treatment of ESCC. More than 20 phase II clinical trials have been launched to explore combinations of ICIs in the neoadjuvant setting for ESCC. Based on our phase II clinical trial, a two-arm phase III trial was launched in Henan Cancer Hospital. ICIs combined with NAC may usher in a new era and may benefit locally advanced, resectable ESCC patients.
A two-arm phase III trial was launched in April 2020 in Henan Cancer Hospital. Patient recruitment will be completed within 18 months. The primary endpoint is event-free survival (EFS). The secondary endpoints include pathologic complete response (pCR), disease-free survival (DFS) rate, overall response rate (ORR), R0 resection rate, major pathologic response (MPR), adverse events (AEs), complication rate and quality of life (QOL). A biobank of pretreatment, resected tumor tissue and paired blood samples will be built for translational research in the future.
This RCT directly compares NAC with neoadjuvant toripalimab plus chemotherapy in terms of EFS for locally advanced ESCC. The results may usher in a new era of resectable ESCC treatment.
NCT04280822 (https://www.clinicaltrials.gov/ct2/show/NCT04280822). Registered title: "A Phase III, Randomized Controlled Study of Neo-adjuvant Toripalimab (JS001) in Combination with Chemotherapy versus Neo-adjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma". Version 1.0/Nov. 21, 2019.
新辅助化疗（NAC）和新辅助放化疗（NACR）是食管鳞状细胞癌（ESCC）的标准治疗方法。然而，5年总生存率（OS）仍远不尽人意。近年来，免疫检查点抑制剂（ICI）在ESCC治疗中显示出了有前景的结果。已经开展了20多项II期临床试验来探索ICI在ESCC新辅助治疗中的联合应用。基于我们的II期临床试验，河南肿瘤医院开展了一项双臂III期试验。ICI联合NAC可能会开创一个新时代，并可能使局部晚期、可切除的ESCC患者受益。
2020年4月在河南肿瘤医院开展了一项双臂III期试验。患者招募将在18个月内完成。主要终点是无事件生存期（EFS）。次要终点包括病理完全缓解（pCR）、无病生存率（DFS）、总缓解率（ORR）、R0切除率、主要病理缓解（MPR）、不良事件（AE）、并发症发生率和生活质量（QOL）。将建立一个包含治疗前、切除的肿瘤组织和配对血液样本的生物样本库，用于未来的转化研究。
这项随机对照试验（RCT）在局部晚期ESCC的EFS方面直接比较了NAC与新辅助托瑞帕利单抗联合化疗的效果。结果可能会开创可切除ESCC治疗的新时代。
