[Translation] A randomized, open-label, phase III trial evaluating sacituzumab govitecan versus physician's choice of treatment 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] Primary Objective: To evaluate the overall survival (OS) of sacituzumab govitecan compared with treatment of physician's choice (TPC) for the treatment of patients with metastatic or locally advanced unresectable urothelial carcinoma (UC). Secondary Objectives: 1. To evaluate and compare the progression-free survival (PFS) of sacituzumab govitecan and TPC treatment, based on the evaluation of the investigator and blinded independent central review (BICR) according to RECIST1.1 criteria. 2. To evaluate and compare the objective response rate (ORR), clinical benefit rate (CBR), and objective duration of tumor response (DOR) of sacituzumab govitecan and TPC treatment, based on the evaluation of the investigator and BICR according to RECIST1.1 criteria. 3. To evaluate and compare the safety and tolerability of sacituzumab govitecan and TPC treatment. 4. To evaluate and compare the quality of life (QOL) of sacituzumab govitecan and TPC treatment.