Pembrolizumab Combined With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy Followed by Surgery for Locally Advanced Oesophageal Squamous Cell Carcinoma: Protocol for a Multicentre, Prospective, Randomized-Controlled, Phase III Clinical Study (Keystone-002)

被引：36

作者：

Shang, Xiaobin ^{[1
]}

Zhang, Wencheng ^{[2
]}

Zhao, Gang ^{[3
]}

Liang, Fei ^{[4
]}

Zhang, Chen ^{[1
]}

Yue, Jie ^{[1
]}

Duan, Xiaofeng ^{[1
]}

Ma, Zhao ^{[1
]}

Chen, Chuangui ^{[1
]}

Pang, Qingsong ^{[2
]}

Zhang, Weihong ^{[5
]}

Liu, Liang ^{[5
]}

Ren, Xiubao ^{[5
]}

Meng, Bin ^{[3
]}

Zhang, Peng ^{[6
]}

Ma, Yegang ^{[7
]}

Zhang, Lin ^{[8
]}

Li, Hecheng ^{[9
]}

Kang, Xiaozheng ^{[10
]}

Li, Yin ^{[10
]}

Jiang, Hongjing ^{[1
]}

机构：

[1] Tianjin Med Univ Canc Inst, Canc Inst& Hosp, Natl Clin Res Ctr Canc, Dept Minimally Invas Esophageal Surg,Key Lab Canc, Tianjin, Peoples R China

[2] Tianjin Med Univ, Canc Inst & Hosp, Key Lab Canc Prevent & Therapy, Natl Clin Res Ctr Canc, Tianjin, Peoples R China

[3] Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Dept Pathol, Key Lab Canc Prevent & Therapy, Tianjin, Peoples R China

[4] Fudan Univ, Zhongshan Hosp, Dept Biostat, Shanghai, Peoples R China

[5] Tianjin Med Univ Canc Inst & Hosp, Natl Clin Res Ctr Canc, Key Lab Canc Prevent & Therapy, Dept Immunol, Tianjin, Peoples R China

[6] Tianjin Med Univ, Gen Hosp, Dept Thorac Surg, Tianjin, Peoples R China

[7] Liaoning Canc Hosp, Dept Thorac Surg, Shenyang, Peoples R China

[8] Shandong First Med Univ, Shandong Prov Hosp, Dept Thorac Surg, Jinan, Peoples R China

[9] Shanghai Jiao Tong Univ, Ruijin Hosp, Sch Med, Dept Thorac Surg, Shanghai, Peoples R China

[10] Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Dept Thorac Surg Oncol, Beijing, Peoples R China

来源：

FRONTIERS IN ONCOLOGY | 2022年 / 12卷

关键词：

oesophageal cancer (EC); neoadjuvant therapy; immunotherapy; efficacy; event-free survival (EFS); QUALITY-OF-LIFE;

D O I：

10.3389/fonc.2022.831345

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

BackgroundTo compare the efficacy and safety of pembrolizumab combined with neoadjuvant chemotherapy (neoCT) versus neoadjuvant chemoradiotherapy (neoCRT) followed by surgery for locally advanced resectable oesophageal squamous cell carcinoma (ESCC). MethodsThis study is a multicentre, prospective, randomized-controlled, phase III clinical study. Eligible ESCC (staging: cT1N2M0 or cT2-3N0-2M0 (stage II/III, high-risk lesions in T2N0M0)) patients will be randomly assigned to either the experimental group (pembrolizumab with neoCT, n = 228) or the control group (neoCRT, n = 114) at a ratio of 2:1. Within 4-6 weeks after preoperative therapy, the McKeown procedure will be performed. Patients in the experimental group will also receive pembrolizumab alone as adjuvant therapy after surgery until 1 year or until the radiographically confirmed PD or other condition indicated for premature termination is observed. The primary endpoint is event-free survival (EFS). The secondary endpoints are 1-, 3-, and 5-year overall survival (OS) and disease-free survival (DFS), short-term outcomes, and quality of life. DiscussionThis is the first prospectively randomized controlled trial designed to compare pembrolizumab plus chemotherapy and chemoradiotherapy as neoadjuvant therapy for resectable ESCC. According to our hypothesis, preoperative pembrolizumab combined with chemotherapy will result in a better tumour response and prolong the survival of patients, with acceptable toxicity. This study started in December 2021, and the enrolment time is estimated to be 2 years.

引用

页数：10