Clinical Trial

HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC

Study acronym: HERO-UTUC
Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07591805
Lead Sponsor RenJi Hospital
Conditions Upper Urinary Tract Urothelial Carcinoma
Enrollment 49 participants
Start Date 2026-05-16
Primary Completion 2027-01-31 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-18