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Clinical Trials in Taiwan / NCT07063758
Active, not recruiting Observational

A Biomarker Study to Predict Treatment Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma

NCT07063758 · tracked via the Priya Life Science Taiwan tracker
Sponsor
National Taiwan University Clinical Trial Center
Phase
Observational
Started
2025-04-01
Last updated
2025-07-16

Condition(s) studied

Advanced Urothelial Carcinoma

Investigational drug(s) / intervention(s)

Biomarker Analysis

Biomarker Analysis: Tumor tissue and serum samples will be collected and analyzed to evaluate the expression of membranous Nectin-4, ADAM10/17, and levels of soluble Nectin-4 (sNectin-4) as predictive biomarkers in patients with advanced urothelial carcinoma receiving standard therapies.

Study summary

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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 20 y/o 2. Histologically confirmed urothelial carcinoma 3. Radiologically documented locally advanced or metastatic disease 4. Exposure to EV (as monotherapy or in combination with pembrolizumab) or first-line platinum-based chemotherapy 5. Complete and identifiable medical records Exclusion Criteria: 1. Inadequate or insufficient tumor tissues for analyses 2. Incomplete medical records

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Taiwan University Hospital Taipei Taiwan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07063758 on ClinicalTrials.gov ↗ ← All trials in Taiwan