Advanced Urothelial Carcinoma
Conditions
Brief 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.
Interventions
OTHERBiomarker 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.
Sponsors
National Taiwan University Clinical Trial Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 24 months | Time from treatment start to disease progression or death from any cause. |
| Overall Survival (OS) | Up to 36 months | Time from treatment initiation to death from any cause. |
| Treatment-Related Adverse Events | Up to 36 months | Incidence and severity of adverse events graded by CTCAE v5.0 during treatment. |
| 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 | To evaluate the correlation between baseline membranous Nectin-4 expression, ADAM10/17 expression (by immunohistochemistry), and serum soluble Nectin-4 levels (by ELISA) with clinical outcomes, including: Overall survival (OS) Progression-free survival (PFS) Objective response rate (ORR) assessed by RECIST v1.1 Treatment-related adverse events graded by CTCAE v5.0 |
Countries
Taiwan
Outcome results
None listed