Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCESO1 trial

Recent single-arm studies of neoadjuvant camrelizumab (PD-1 inhibitor) plus chemotherapy for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC) showed promising results. This multicenter, randomized, open-label phase 3 trial compared neoadjuvant camrelizumab plus chemotherapy followed by adjuvant camrelizumab versus neoadjuvant chemotherapy alone. A total of 391 patients with resectable thoracic LA-ESCC (T1b-3N1-3M0 or T3N0M0) were randomized 1:1:1 to camrelizumab+albumin-bound paclitaxel+cisplatin (Cam+nab-TP; n=132), camrelizumab+paclitaxel+cisplatin (Cam+TP; n=130), or paclitaxel+cisplatin (TP; n=129), then surgery; Cam arms also received adjuvant camrelizumab. Dual primary endpoints were pathological complete response (PCR, by blinded independent review committee) and event-free survival (EFS, by investigators). This report presents final PCR results. In the intention-to-treat population, PCR rates were 28.0% (Cam+nab-TP) and 15.4% (Cam+TP) versus 4.7% (TP) (Cam+nab-TP vs TP: difference 23.5%, 95% CI 15.1–32.0, P<0.0001; Cam+TP vs TP: difference 10.9%, 95% CI 3.7–18.1, P=0.0034). EFS is not yet mature. Grade ≥3 treatment-related adverse events during neoadjuvant therapy occurred in 34.1%, 29.2%, and 28.8%, respectively; postoperative complication rates were 34.2%, 38.8%, and 32.0%. Neoadjuvant camrelizumab plus chemotherapy improved PCR versus chemotherapy alone with acceptable safety. ChiCTR2000040034.

Jianjun Qin, Liyan Xue, Anlin Hao, Xiaofeng Guo, Tao Jiang, Yunfeng Ni, Shuoyan Liu, Yujie Chen, Hongjing Jiang, Chen Zhang, Mingqiang Kang, Jihong Lin, Hecheng Li, Chengqiang Li, Hui Tian, Lin Li, Junke Fu, Yong Zhang, Jianqun Ma, Xiaoyuan Wang, Maoyong Fu, Hao Yang, Zhaoyang Yang, Yongtao Han, Longqi Chen, Lijie Tan, Tianyang Dai, Yongde Liao, Weiguo Zhang, Bin Li, Qixun Chen, Shiping Guo, Yu Qi, Li Wei, Zhigang Li, Ziqiang Tian, Xiaozheng Kang, Ruixiang Zhang, Yong Li, Zhen Wang, Xiankai Chen, Zhiguo Hou, Rongrong Zheng, Wenqing Zhu, Jie He, Yin Li