Biomarker Studies to Predict Treatment Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study aims to find biological markers that help predict how patients with advanced urothelial carcinoma respond to treatment with enfortumab vedotin (EV) or EV-based combination therapies. Since EV can cause significant side effects and is costly, identifying markers such as nectin-4 and related proteins in tumor tissue and blood may help doctors personalize treatment plans. The investigators will enroll about 100 patients receiving EV and compare them to another 100 patients treated with standard chemotherapy. By studying tissue samples and blood at different times, the investigators hope to discover which markers best indicate treatment success or risks. This research could lead to better, safer treatments tailored to each patient's biology.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 y/o
- •Histologically confirmed urothelial carcinoma
- •Radiologically documented locally advanced or metastatic disease
- •Exposure to EV (as monotherapy or in combination with pembrolizumab) or first-line platinum-based chemotherapy
- •Complete and identifiable medical records
排除标准
- •Inadequate or insufficient tumor tissues for analyses
- •Incomplete medical records
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 12 months after treatment initiation
Proportion of patients achieving complete or partial tumor response according to RECIST 1.1 criteria after enfortumab vedotin treatment.
次要结局
- Treatment-Related Adverse Events(Up to 36 months)
- Progression-Free Survival (PFS)(Up to 24 months)
- Overall Survival (OS)(Up to 36 months)
- Association of Nectin-4, ADAM10/17 Expression and Serum Soluble Nectin-4 with Overall Survival, Progression-Free Survival, Objective Response Rate, and Adverse Events(Assessed at baseline and up to 36 months)
研究者
National Taiwan University Clinical Trial Center
National Taiwan University Hospital Clinical Trial Center
National Taiwan University Hospital