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

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单位: [1]Sun Yat Sen Univ, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med, Dept Med Oncol,Canc Ctr, Guangzhou 510060, Peoples R China [2]Chinese Acad Med Sci, Res Unit Precis Diag & Treatment Gastrointestinal, Guangzhou 510060, Peoples R China [3]Chinese Acad Med Sci, Canc Hosp, Beijing 100021, Peoples R China [4]Henan Univ Sci & Technol, Affiliated Hosp 1, Luoyang 471000, Peoples R China [5]Harbin Med Univ, Canc Hosp, Harbin 150081, Peoples R China [6]Army Med Ctr PLA, Chongqing 400042, Peoples R China [7]Jiangsu Canc Hosp, Nanjing 210009, Peoples R China [8]Zhengzhou Univ, Henan Canc Hosp, Zhengzhou 450008, Peoples R China [9]Zhengzhou Univ, Affiliated Canc Hosp, Zhengzhou 450008, Peoples R China [10]Zhejiang Canc Hosp, Hangzhou 310022, Peoples R China [11]Linyi Canc Hosp, Linyi 276000, Shandong, Peoples R China [12]Northern Jiangsu Peoples Hosp, Yangzhou 225001, Jiangsu, Peoples R China [13]Beijing Canc Hosp, Beijing 100142, Peoples R China [14]Jiangsu Prov Hosp, Nanjing 210029, Peoples R China [15]Southeast Univ, Zhongda Hosp, Nanjing 210009, Peoples R China [16]Southwest Med Univ, Affiliated Hosp, Luzhou 646000, Peoples R China [17]Shanghai Chest Hosp, Shanghai 200030, Peoples R China [18]Guangxi Med Univ, Affiliated Tumor Hosp, Nanning 530000, Peoples R China [19]Fujian Canc Hosp, Fuzhou 350000, Peoples R China [20]Shandong Canc Hosp, Jinan 250117, Peoples R China [21]Zhejiang Univ, Sir Run Run Shaw Hosp, Sch Med, Hangzhou 310000, Peoples R China [22]Henan Prov Peoples Hosp, Zhengzhou 450000, Peoples R China [23]Shantou Univ, Affiliated Canc Hosp, Coll Med, Shantou 515000, Peoples R China [24]Jining Med Univ, Affiliated Hosp, Jining 272000, Peoples R China [25]Jiangmen Cent Hosp, Jiangmen 529000, Peoples R China [26]Anhui Med Univ, Hosp 2, Hefei 230000, Peoples R China [27]Hebei Med Univ, Hosp 4, Shijiazhuang 050000, Hebei, Peoples R China [28]Xiamen Univ, Affiliated Hosp 1, Xiamen 361000, Peoples R China [29]Nanjing Drum Tower Hosp, Nanjing 530000, Peoples R China [30]Anyang Canc Hosp, Anyang 455000, Peoples R China [31]Hunan Canc Hosp, Changsha 410000, Peoples R China [32]Sichuan Univ, West China Hosp, Chengdu 610000, Peoples R China [33]Xinxiang Med Univ, Affiliated Hosp 1, Weihui 453100, Peoples R China [34]Jinan Cent Hosp, Jinan 250000, Peoples R China [35]Wuhan Univ, Zhongnan Hosp, Wuhan 430000, Peoples R China [36]Zhengzhou Univ, Henan Canc Hosp, Zhengzhou 450000, Peoples R China [37]Zhengzhou Univ, Affiliated Canc Hosp, Zhengzhou 450000, Peoples R China [38]Sichuan Canc Hosp, Chengdu 610000, Peoples R China [39]Xijing Hosp, Xian 710000, Peoples R China [40]Shanghai Gen Hosp, Shanghai 200000, Peoples R China [41]Nantong Tumor Hosp, Nantong 226000, Peoples R China [42]Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Wuhan 430000, Peoples R China [43]Yichang Cent Peoples Hosp, Yichang 443000, Peoples R China [44]China Med Univ, Hosp 1, Shenyang 110000, Peoples R China [45]Jinzhou Med Univ, Affiliated Hosp 1, Jinzhou 121000, Peoples R China [46]Liuzhou Peoples Hosp, Liuzhou 545000, Peoples R China [47]China Japan Friendship Hosp, Beijing 100000, Peoples R China [48]Jilin Univ, Bethune Hosp 1, Changchun 130000, Peoples R China [49]Southern Med Univ, Nanfang Hosp, Guangzhou 510000, Peoples R China [50]Liaoning Canc Hosp & Inst, Shenyang 110000, Peoples R China [51]North Sichuan Med Coll, Affiliated Hosp, Nanchong 637000, Peoples R China [52]Guangxi Med Univ, Affiliated Hosp 1, Nanning 530000, Peoples R China [53]Zhengzhou Univ, Affiliated Hosp 1, Zhengzhou 450000, Peoples R China [54]Xinxiang First Peoples Hosp, Xinxiang 453000, Henan, Peoples R China [55]Zhejiang Univ, Affiliated Hosp 2, Sch Med, Hangzhou 310000, Peoples R China [56]Shantou Univ, Affiliated Hosp 2, Coll Med, Shantou 515000, Peoples R China [57]Shijiazhuang Peoples Hosp, Shijiazhuang 050000, Hebei, Peoples R China [58]Guangdong Med Univ, Affiliated Hosp, Zhanjiang 524000, Peoples R China [59]Second Peoples Hosp Yibin, Yibin 644000, Peoples R China [60]Chinese Peoples Liberat Army Gen Hosp, Beijing 100000, Peoples R China [61]Guangzhou Med Univ, Affiliated Hosp 1, Guangzhou 510000, Peoples R China [62]Nanchang Univ, Affiliated Hosp 1, Nanchang 330000, Jiangxi, Peoples R China [63]Army Med Univ, Affiliated Hosp 2, Chongqing 400037, Peoples R China [64]Xuzhou Cent Hosp, Xuzhou 221000, Jiangsu, Peoples R China [65]Jiangxi Canc Hosp, Nanchang 330000, Jiangxi, Peoples R China [66]Tongji Hosp, Tongji Med Coll, Wuhan 430000, Peoples R China [67]Shanxi Bethune Hosp, Taiyuan 030000, Peoples R China [68]Chinese Peoples Liberat Army, 900th Hosp, Joint Logist Support Force, Fuzhou 350000, Peoples R China [69]Anhui Prov Canc Hosp, Hefei 230000, Peoples R China [70]Qingdao Cent Hosp, Qingdao 266000, Peoples R China [71]HanDan Cent Hosp, Handan 056000, Peoples R China [72]Tianjin Med Univ, Canc Inst & Hosp, Tianjin 300000, Peoples R China [73]Jilin Univ, Hosp 2, Changchun 130000, Peoples R China [74]Shandong Prov Hosp, Jinan 250000, Peoples R China [75]HuBei Canc Hosp, Wuhan 430000, Peoples R China [76]Shanghai Junshi Biosci, Shanghai 200126, Peoples R China [77]TopAlliance Biosci, Rockville, MD 20850 USA
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摘要:
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-naive 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 pre specified 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 pre specified 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 R3 treatment-emergent adverse events are similar between the two arms. Toripalimab plus TP significantly improves PFS and OS in patients with treatment-naive, advanced ESCC, with a manageable safety profile.

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出版当年[2021]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 细胞生物学
最新[2025]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[2020]版:
Q1 ONCOLOGY Q1 CELL BIOLOGY
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[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者:
第一作者单位: [1]Sun Yat Sen Univ, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med, Dept Med Oncol,Canc Ctr, Guangzhou 510060, Peoples R China [2]Chinese Acad Med Sci, Res Unit Precis Diag & Treatment Gastrointestinal, Guangzhou 510060, Peoples R China
通讯作者:
通讯机构: [1]Sun Yat Sen Univ, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med, Dept Med Oncol,Canc Ctr, Guangzhou 510060, Peoples R China [2]Chinese Acad Med Sci, Res Unit Precis Diag & Treatment Gastrointestinal, Guangzhou 510060, Peoples R China
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