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HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC
Sponsor: RenJi Hospital
Summary
This is a prospective, single-center, single-arm phase II study evaluating whether a single postoperative intravesical instillation of disitamab vedotin (RC48) can reduce bladder recurrence after radical nephroureterectomy (RNU) in patients with HER2-positive upper tract urothelial carcinoma (UTUC). Eligible patients will receive one intravesical instillation of RC48 within 96 hours after surgery. The primary objective is to determine the 12-month intravesical recurrence rate. Serial urine samples will be prospectively collected to evaluate urinary methylation biomarkers for early recurrence detection.
Official title: A Prospective Phase II Study of Single Postoperative Intravesical Disitamab Vedotin to Prevent Bladder Recurrence After Radical Nephroureterectomy in HER2-Positive Upper Tract Urothelial Carcinoma
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
49
Start Date
2026-05-16
Completion Date
2028-01-31
Last Updated
2026-05-18
Healthy Volunteers
No
Conditions
Interventions
Drug: Disitamab Vedotin
Participants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy.
Locations (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China