NCT03399643终止不适用
Non-Interventional Study To Investigate The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 32
- 主要终点
- Overall Survival Rate (OS rate)
研究概览
简要总结
The objective of this study is to investigate the effectiveness of Atezolizumab with a primary focus on the overall survival (OS) rate at 2 years and secondary focuses on quality of life (QoL) and the sequence of treatment in mUC patients. Furthermore, this study aims at collecting data on safety of Atezolizumab and on the reason for cisplatin-ineligibility
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic UC (Urothelial Carcinoma) including cancers of the renal pelvis, ureters, urinary bladder, and urethra
- •Will be receiving atezolizumab for the treatment of inoperable locally-advanced or metastatic UC, per the decision of the treating physician
- •Have adequate hematologic and end-organ functions
- •Have had no prior palliative chemotherapy for inoperable locally-advanced or metastatic UC and are clinically ineligible ("unfit") for cisplatin-based chemotherapy
排除标准
- •Have received prior immune checkpoint therapy
- •Are pregnant or breastfeeding
- •Are included in any other trial
结局指标
主要结局
Overall Survival Rate (OS rate)
时间窗: 2 years
次要结局
- Median Overall Survival (OS)(Initiation of study treatment until death or end of study, approximately 4 years)
- Percentage of participants with adverse events(Up to approximately 4 years)
- Median Progression Free Survival (PFS)(Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years))
研究者
研究点 (32)
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