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Efficacy and Safety of Sintilimab in Combination with Concurrent Chemoradiotherapy for Locally Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (SHARED): Study Protocol of a Prospective, Multi-Center, Single-Arm Phase 2 Trial 期刊论文

编号：

963B9B773C4DB5FD7B240E4FB72D91F1
作者：

Wei, Jia(魏嘉)#^[1,2]Lu, Xiaofeng(陆晓峰)^[3]Liu, Qin(刘芹)^[1,2]Fu, Yao(付尧)^[4]Liu, Song(刘松)^[5]Li, Lin(李琳)^[4]Liu, Fangcen(刘芳岑)^[4]Fan, Xiangshan(樊祥山)^[4]Yang, Ju(杨菊)^[1,2]Yang, Yang(杨阳)^[1,2]Zhao, Yang(赵杨)^[6]Guan, Wenxian(管文贤)^[3]Liu, Baorui(刘宝瑞)*^[1,2]
语种：

英文
期刊：

CANCER MANAGEMENT AND RESEARCH ISSN：1179-1322 2022 年 14 卷 (2007 - 2015)
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关键词：

anti-PD-1 induction chemotherapy chemoradiotherapy immunotherapy
摘要：

Purpose: Concurrent chemoradiotherapy (cCRT) is the mainstay therapy of locally advanced gastric (G) and gastroesophageal junction (GEJ) cancers with a poor prognosis. Programmed cell death receptor-1 (PD-1) inhibitor has been approved and recommended to treat >= 3 line G/GEJ patients. A significant clinical benefit of PD-1 inhibitors in addition to cCRT has been observed in locally advanced lung cancer. Sintilimab, a humanized IgG4 monoclonal antibody with high affinity and specificity for PD-1, has shown promising efficacy with an overall response rate of 85% in combination with chemotherapy in gastric cancer in a phase Ib study (NCT02937116). Patients and Methods: SHARED is a prospective, multicentre, single-arm Phase II trial in China, exploring the efficacy of sintilimab in combination with cCRT in locally advanced G/GEJ adenocarcinoma. According to a Simon optimal two-stage clinical design, 34 patients will be enrolled. All the eligible patients will receive one cycle of induction chemotherapy (S-1 plus nab-PTX) combined with sintilimab, followed by cCRT (radiotherapy plus nab-PTX) combined with sintilimab. Prior to the surgery, patients will receive another cycle of chemotherapy (S-1 plus nab-PTX) combined with sintilimab. In the adjuvant setting, all participants will be treated with 3 cycles of chemotherapy (S-1 plus nab-PTX) combined with sintilimab. The primary endpoint is the rate of pathological complete response (pCR). The secondary endpoints include disease-free survival (DFS), major pathological response (MPR), R0 resection rate, surgical AEs, overall survival (OS), event-free survival (EFS), and safety profile. Moreover, the prognostic value of tumor biomarkers and immune biomarkers will be explored. Conclusion: SHARED is designed to primally evaluate the efficacy and safety of sintilimab in combination with cCRT in locally advanced G/GEJ cancers and to prospectively validate the prognostic value of tumor biomarkers and immune biomarkers.
推荐引用方式
GB/T 7714：

Wei Jia,Lu Xiaofeng,Liu Qin, et al. Efficacy and Safety of Sintilimab in Combination with Concurrent Chemoradiotherapy for Locally Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (SHARED): Study Protocol of a Prospective, Multi-Center, Single-Arm Phase 2 Trial [J].CANCER MANAGEMENT AND RESEARCH,2022,14:2007-2015.
APA：

Wei Jia,Lu Xiaofeng,Liu Qin,Fu Yao,&Liu Baorui.(2022).Efficacy and Safety of Sintilimab in Combination with Concurrent Chemoradiotherapy for Locally Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (SHARED): Study Protocol of a Prospective, Multi-Center, Single-Arm Phase 2 Trial .CANCER MANAGEMENT AND RESEARCH,14:2007-2015.
MLA：

Wei Jia, et al. "Efficacy and Safety of Sintilimab in Combination with Concurrent Chemoradiotherapy for Locally Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (SHARED): Study Protocol of a Prospective, Multi-Center, Single-Arm Phase 2 Trial" .CANCER MANAGEMENT AND RESEARCH 14(2022):2007-2015.
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7/9/2022 8:37:56 PM
更新时间：

7/9/2022 8:37:56 PM
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