Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial

Author:

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

Abstract

AbstractRecent single-arm studies involving neoadjuvant camrelizumab, a PD-1 inhibitor, plus chemotherapy for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC) have shown promising results. This multicenter, randomized, open-label phase 3 trial aimed to further assess the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy followed by adjuvant camrelizumab, compared to neoadjuvant chemotherapy alone. A total of 391 patients with resectable thoracic LA-ESCC (T1b-3N1-3M0 or T3N0M0) were stratified by clinical stage (I/II, III or IVA) and randomized in a 1:1:1 ratio to undergo two cycles of neoadjuvant therapy. Treatments included camrelizumab, albumin-bound paclitaxel and cisplatin (Cam+nab-TP group; n = 132); camrelizumab, paclitaxel and cisplatin (Cam+TP group; n = 130); and paclitaxel with cisplatin (TP group; n = 129), followed by surgical resection. Both the Cam+nab-TP and Cam+TP groups also received adjuvant camrelizumab. The dual primary endpoints were the rate of pathological complete response (pCR), as evaluated by a blind independent review committee, and event-free survival (EFS), as assessed by investigators. This study reports the final analysis of pCR rates. In the intention-to-treat population, the Cam+nab-TP and Cam+TP groups exhibited significantly higher pCR rates of 28.0% and 15.4%, respectively, compared to 4.7% in the TP group (Cam+nab-TP versus TP: difference 23.5%, 95% confidence interval (CI) 15.1–32.0, P < 0.0001; Cam+TP versus TP: difference 10.9%, 95% CI 3.7–18.1, P = 0.0034). The study met its primary endpoint of pCR; however, EFS is not yet mature. The incidence of grade ≥3 treatment-related adverse events during neoadjuvant treatment was 34.1% for the Cam+nab-TP group, 29.2% for the Cam+TP group and 28.8% for the TP group; the postoperative complication rates were 34.2%, 38.8% and 32.0%, respectively. Neoadjuvant camrelizumab plus chemotherapy demonstrated superior pCR rates compared to chemotherapy alone for LA-ESCC, with a tolerable safety profile. Chinese Clinical Trial Registry identifier: ChiCTR2000040034.

Publisher

Springer Science and Business Media LLC

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