Neurological Function in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin-Based Therapy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

About this trial

This prospective observational study aims to evaluate the correlation between neurological function and patient-reported symptoms of peripheral neuropathy (PN) in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) receiving enfortumab vedotin (EV)-based therapy. A total of 100 patients will be enrolled between March 2025 and December 2029. Eligible participants will undergo comprehensive neurological assessments, including neurological examination(NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These assessments will be conducted at baseline and every three months until six months after completion of EV-based therapy. Patient characteristics and oncological outcomes will also be collected. This study seeks to identify risk factors for developing PN and to explore the clinical implications of EV-associated neurological changes, with the ultimate goal of optimizing treatment strategies and improving quality of life.

Eligibility criteria

Qualifiers

Age ≥ 20 y/o

Histologically confirmed urothelial carcinoma

Radiologically documented locally advanced or metastatic disease

Prepare for receiving EV (as monotherapy or in combination with immune checkpoint inhibitors)

Disqualifiers

Do not agree to receive regular neurological examinations

Do not agree to provide complete medical records during treatment

Trial design

Treatments tested in this trial

  • Neurological function assessment

Treatment groups

100 Participants
are divided into 1 treatment group