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作者

Feng Wang Gong Chen Meng Qiu Jinfeng Ma Xianwei Mo Haiyi Liu Yongqiang Li Peirong Ding Xiangbin Wan Yingbin Hu Xiwen Huang Weiqin Jiang Xiaojun Wu Jia Luo Yanbing Zhou Leping Li Yanlai Sun Quan Wang Nanya Wang Wu Jiang

作者单位

²³Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China ²⁶The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China ²²Guangxi Medical University Cancer Hospital, Nanning, China ⁴Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China ¹¹Zhejiang Cancer Hospital, Hangzhou, China ¹⁹Innovent Biologics (Suzhou) Co., Ltd., Suzhou, China ¹²The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China ⁵Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, China ⁷The Third Bethune Hospital of Jilin University, Changchun, China ²⁹Shandong Cancer Hospital, Jinan, China ²⁰West China Hospital of Sichuan University, Chengdu, China ³These authors contributed equally ²⁴Hunan Cancer Hospital, Changsha, China ¹⁶Mianyang Central Hospital, Mianyang, China ³⁰First Hospital of Jilin University, Changchun, China ²⁸Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China ¹⁸The Frist Affiliated Hospital of Xiamen University, Xiamen, China ¹⁰Tianjin Cancer Hospital Airport Hospital, Tianjin, China ⁸Xiangya Hospital of Central South University, Changsha, China ¹³Jiangsu Province Hospital, Nanjing, China ²¹Shanxi Cancer Hospital, Taiyuan, China ²Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China ⁶The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China ¹⁴Zhongshan Hospital of Fudan University, Shanghai, China ¹⁵Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China ⁹The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China ¹Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, China ²⁷The Affiliated Hospital of Qingdao University, Qingdao, China ²⁵Meizhou People’s Hospital, Meizhou, China ¹⁷The Frist Affiliated Hospital of Nanchang University, Nanchang, China

刊名

Cancer Cell

年份

2025

卷号

Vol.43 No.10

页码

1958-1967(e2)

ISSN

1535-6108

关键词

anti-CLTA-4 anti-PD-1 immunotherapy microsatellite instability-high mismatch repair-deficient colon cancer

摘要

Although neoadjuvant immunotherapy showed promising efficacy in locally advanced microsatellite instability-high or mismatch repair-deficient colon cancer, whether dual immune checkpoint inhibition provides additional benefit over anti-PD-1 monotherapy remains unclear. This randomized phase 1b trial evaluated a neoadjuvant regimen of IBI310 plus sintilimab versus sintilimab monotherapy . Surgery was performed in 51 and 45 patients, respectively. The primary endpoint, pathological complete re...更多

Although neoadjuvant immunotherapy showed promising efficacy in locally advanced microsatellite instability-high or mismatch repair-deficient colon cancer, whether dual immune checkpoint inhibition provides additional benefit over anti-PD-1 monotherapy remains unclear. This randomized phase 1b trial evaluated a neoadjuvant regimen of IBI310 plus sintilimab versus sintilimab monotherapy . Surgery was performed in 51 and 45 patients, respectively. The primary endpoint, pathological complete response rate, was significantly higher in the combination compared to the monotherapy arm within the modified intent-to-treat population , with consistent results in the intent-to-treat population . Safety in both arms was comparable and manageable without new safety signals. After a median follow-up of 21.4 months, no disease recurrences occurred. One death occurred in each arm due to postoperative complication and adverse events. These findings demonstrate the added benefit of neoadjuvant IBI310 plus sintilimab over sintilimab monotherapy for locally advanced MSI-H/dMMR colon cancer.收起

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