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Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial.

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机构: [1]Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, CollaborativeInnovation Center of Cancer Medicine, Guangzhou 510060, China [2]Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou510060, China [3]Cancer Hospital Chinese Academy of Medical Sciences, Beijing 100021, China [4]The First Affiliated Hospital of Henan University of Science and Technology, Luoyang 471000, China [5]Harbin Medical University Cancer Hospital, Harbin 150081, China [6]Army Medical Center of PLA, Chongqing 400042, China [7]Jiangsu Cancer Hospital, Nanjing 210009, China [8]Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China [9]Zhejiang Cancer Hospital, Hangzhou 310022, China [10]Linyi Cancer Hospital, Linyi 276000, China [11]The Northern Jiangsu People’s Hospital, Yangzhou 225001, China [12]Beijing Cancer Hospital, Beijing 100142, China [13]Jiangsu Province Hospital, Nanjing 210029, China [14]Zhongda Hospital Southeast University, Nanjing 210009, China [15]The Affiliated Hospital of Southwest Medical University, Luzhou 646000, China [16]Shanghai Chest Hospital, Shanghai 200030, China [17]Guangxi Medical University Affiliated Tumor Hospital, Nanning 530000, China [18]Fujian Cancer Hospital, Fuzhou 350000, China [19]Shandong Cancer Hospital, Jinan 250117, China [20]Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou 310000, China [21]Henan Provincial People’s Hospital, Zhengzhou 450000, China [22]The Affiliated Cancer Hospital of Shantou University Medical College, Shantou 515000, China [23]Affiliated Hospital of Jining Medical University, Jining 272000, China [24]Jiangmen Central Hospital, Jiangmen 529000, China [25]The Second Hospital of Anhui Medical University, Hefei 230000, China [26]The Fourth Hospital of Hebei Medical University, Shijiazhuang 050000, China [27]The First Affiliated Hospital of Xiamen University, Xiamen 361000, China [28]Nanjing Drum Tower Hospital, Nanjing 530000, China [29]Anyang Cancer Hospital, Anyang 455000, China [30]Hunan Cancer Hospital, Changsha 410000, China [31]West China Hospital of Sichuan University, Chengdu 610000, China [32]The First Affiliated Hospital of Xinxiang Medical University, Weihui 453100, China [33]Jinan Central Hospital, Jinan 250000, China [34]Zhongnan Hospital of Wuhan University, Wuhan 430000, China [35]Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450000, China [36]Sichuan Cancer Hospital, Chengdu 610000, China [37]Xijing Hospital, Xi’an 710000, China [38]Shanghai General Hospital, Shanghai 200000, China [39]Nantong Tumor Hospital, Nantong 226000, China [40]Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430000, China [41]Yichang Central People’s Hospital, Yichang 443000, China [42]The First Hospital of China Medical University, Shenyang 110000, China [43]The First Affiliated Hospital of Jinzhou Medical University, Jinzhou 121000, China [44]Liuzhou People’s Hospital, Liuzhou 545000, China [45]China-Japan Friendship Hospital, Beijing 100000, China [46]The First Bethune Hospital of Jilin University, Changchun 130000, China [47]Nanfang Hospital Southern Medical University, Guangzhou 510000, China [48]Liaoning Cancer Hospital & Institute, Shenyang 110000, China [49]The Affiliated Hospital of North Sichuan Medical College, Nanchong 637000, China [50]The First Affiliated Hospital of Guangxi Medical University, Nanning 530000, China [51]The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China [52]Xinxiang First People’s Hospital, Xinxiang 453000, China [53]The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310000, China [54]The Second Affiliated Hospital of Shantou University Medical College, Shantou 515000, China [55]Shijiazhuang People’s Hospital, Shijiazhuang 050000, China [56]Affiliated Hospital of Guangdong Medical University, Zhanjiang 524000, China [57]The Second People’s Hospital of Yibin, Yibin 644000, China [58]Chinese PLA General Hospital, Beijing 100000, China [59]The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510000, China [60]The First Affiliated Hospital of Nanchang University, Nanchang 330000, China [61]The Second Affiliated Hospital of Army Medical University, Chongqing 400037, China [62]Xuzhou Central Hospital, Xuzhou 221000, China [63]Jiangxi Cancer Hospital, Nanchang 330000, China [64]Tongji Hospital Affiliated to Tongji Medical College, Wuhan 430000, China [65]Shanxi Bethune Hospital, Taiyuan 030000, China [66]The 900th Hospital of the Joint Logistic Support Force of the Chinese People’s Liberation Army, Fuzhou 350000, China [67]Anhui Provincial Cancer Hospital, Hefei 230000, China [68]Qingdao Central Hospital, Qingdao 266000, China [69]HanDan Central Hospital, Handan 056000, China [70]Tianjin Medical University Cancer Institute & Hospital, Tianjin 300000, China [71]The Second Hospital of Jilin University, Changchun 130000, China [72]Shandong Provincial Hospital, Jinan 250000, China [73]HuBei Cancer Hospital, Wuhan 430000, China [74]Shanghai Junshi Biosciences, Shanghai 200126, China [75]TopAlliance Biosciences, Rockville, MD 20850, USA
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Platinum-based chemotherapy is the standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In this phase 3 study (ClinicalTrial.gov: NCT03829969), 514 patients with treatment-naïve advanced ESCC were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin (TP) every 3 weeks for up to 6 cycles, followed by toripalimab or placebo maintenance. At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS is observed for the toripalimab arm over the placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46-0.74; p < 0.0001). The prespecified interim analysis of overall survival (OS) also reveals a significant OS improvement for patients treated with toripalimab plus TP over placebo plus TP (HR = 0.58; 95% CI, 0.43-0.78; p = 0.0004). The incidences of grade ≥3 treatment-emergent adverse events are similar between the two arms. Toripalimab plus TP significantly improves PFS and OS in patients with treatment-naïve, advanced ESCC, with a manageable safety profile.Copyright © 2022 Elsevier Inc. All rights reserved.

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出版当年[2022]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 细胞生物学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 细胞生物学 1 区 肿瘤学
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出版当年[2022]版:
Q1 CELL BIOLOGY Q1 ONCOLOGY
最新[2023]版:
Q1 CELL BIOLOGY Q1 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者:
第一作者机构: [1]Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, CollaborativeInnovation Center of Cancer Medicine, Guangzhou 510060, China [2]Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou510060, China
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通讯作者:
通讯机构: [1]Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, CollaborativeInnovation Center of Cancer Medicine, Guangzhou 510060, China [2]Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou510060, China
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