研究单位:[1]BeiGene[2]Tongji Hospital, Tongji Medical College Huangzhong University of Science &Technology Wuhan, Hubei, China[3]Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei, China[4]Xiangya Hospital of Central South University Changsha, Hunan, China[5]Jiangsu Province Cancer Hospital Nanjing, Jiangsu, China[6]Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School Nanjing, Jiangsu, China[7]The First Affiliated Hospital of Nanchang University Nanchang, Jiangxi, China[8]The First Hospital of Jilin University Changchun, Jilin, China[9]Liaoning Cancer Hospital & Institute Shenyang, Liaoning, China[10]Affiliated Zhongshan Hospital of Fudan University Shanghai, Shanghai, China[11]Fudan University Shanghai Cancer Center Shanghai, Shanghai, China[12]Huadong Hospital Affiliated to Fudan University Shanghai, Shanghai, China[13]Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China[14]Shanghai Changhai Hospital Shanghai, Shanghai, China[15]The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an, Shanxi, China[16]Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital Chengdu, Sichuan, China[17]West China Hospital,Sichuan University / West China Hospital of Medicine, Sichuan University Chengdu, Sichuan, China[18]The Second Affiliated Hospital of Tianjin Medical University Tianjin, Tianjin, China[19]Affiliated Cancer Hospital of Xinjiang Medical University Ürümqi, Xinjiang, China[20]Yunnan Province Cancer Hospital Kunming, Yunnan, China
研究目的:
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin + gemcitabine versus placebo+ either cisplatin or carboplatin + gemcitabine in approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.