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

文献类型：期刊论文

作者Qin, Jianjun27; Xue, Liyan26; Hao, Anlin25; Guo, Xiaofeng25; Jiang, Tao24; Ni, Yunfeng24; Liu, Shuoyan23; Chen, Yujie23; Jiang, Hongjing22; Zhang, Chen22
刊名NATURE MEDICINE
出版日期2024-07-02
ISSN号1078-8956
DOI10.1038/s41591-024-03064-w
通讯作者He, Jie(hejie@cicams.ac.cn) ; Li, Yin(liyin@cicams.ac.cn)
英文摘要Recent 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.
WOS关键词PEMBROLIZUMAB PLUS CHEMOTHERAPY ; SOLVENT-BASED PACLITAXEL ; PREOPERATIVE CHEMORADIOTHERAPY ; COMPLETE RESPONSE ; SINGLE-ARM ; OPEN-LABEL ; PLACEBO ; COMPLICATIONS ; MULTICENTER ; PROGNOSIS
资助项目Jiangsu Hengrui Pharmaceuticals
WOS研究方向Biochemistry & Molecular Biology ; Cell Biology ; Research & Experimental Medicine
语种英语
WOS记录号WOS:001261267800001
出版者NATURE PORTFOLIO
资助机构Jiangsu Hengrui Pharmaceuticals
源URL[http://ir.hfcas.ac.cn:8080/handle/334002/136692]  
专题中国科学院合肥物质科学研究院
通讯作者He, Jie; Li, Yin
作者单位1.Sichuan Univ, Dept Thorac Surg, West China Hosp, Chengdu, Peoples R China
2.Fudan Univ, Zhongshan Hosp, Dept Thorac Surg, Shanghai, Peoples R China
3.Southwest Med Univ, Dept Thorac Surg, Affiliated Hosp, Luzhou, Peoples R China
4.Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Thorac Surg, Wuhan, Peoples R China
5.Henan Univ Sci & Technol, Affiliated Hosp 1, Surg Esophageal Canc, Luoyang, Peoples R China
6.Shandong Univ, Dept Thorac Surg, Qilu Hosp, Jinan, Peoples R China
7.Lanzhou Univ, Clin Med Sch, Lanzhou, Peoples R China
8.Univ Chinese Acad Sci, Zhejiang Canc Hosp, Canc Hosp, Dept Thorac Surg, Hangzhou, Peoples R China
9.Shanxi Prov Canc Hosp, Dept Thorac Surg, Taiyuan, Peoples R China
10.Zhengzhou Univ, Affiliated Hosp 1, Dept Thorac Surg, Zhengzhou, Peoples R China
推荐引用方式
GB/T 7714		 Qin, Jianjun,Xue, Liyan,Hao, Anlin,et al. Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial[J]. NATURE MEDICINE,2024.
APA Qin, Jianjun.,Xue, Liyan.,Hao, Anlin.,Guo, Xiaofeng.,Jiang, Tao.,...&Li, Yin.(2024).Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial.NATURE MEDICINE.
MLA Qin, Jianjun,et al."Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial".NATURE MEDICINE (2024).

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来源：合肥物质科学研究院

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