[Translation] A randomized, open-label, phase III trial evaluating sacituzumab govitecan versus physician's choice therapy in patients with metastatic or locally advanced unresectable urothelial carcinoma
主要目的:评估Sacituzumab Govitecan相较于医生选择的治疗(TPC)用于治疗转移性或者局部晚期不可切除的尿路上皮癌(UC)患者的总生存期(OS)。次要目的:1. 评估并比较sacituzumab govitecan与TPC治疗的无进展生存期(PFS),基于研究者和盲态独立中心审查(BICR)根据RECIST1.1标准的评估。2. 评估并比较sacituzumab govitecan与TPC治疗的客观缓解率(ORR)、临床获益率(CBR)和客观肿瘤缓解持续时间(DOR),基于研究者和BICR根据RECIST1.1标准的评估。3. 评估并比较sacituzumab govitecan和TPC治疗的安全性和耐受性。4. 评估并比较sacituzumab govitecan和TPC治疗的生活质量(QOL)。
[Translation] MAIN OBJECTIVE: To evaluate the overall survival (OS) of sacituzumab govitecan compared with physician's choice (TPC) in patients with metastatic or locally advanced unresectable urothelial carcinoma (UC). Secondary objectives: 1. To assess and compare progression-free survival (PFS) between sacituzumab govitecan and TPC treatment, based on investigator and blinded independent central review (BICR) assessments according to RECIST 1.1 criteria. 2. To evaluate and compare the objective response rate (ORR), clinical benefit rate (CBR) and objective tumor response duration (DOR) of sacituzumab govitecan and TPC therapy based on investigator and BICR assessments according to RECIST1.1 criteria. 3. To evaluate and compare the safety and tolerability of sacituzumab govitecan and TPC therapy. 4. To assess and compare the quality of life (QOL) of sacituzumab govitecan and TPC treatment.