HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorRenJi Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years.
Histologically or radiologically suspected UTUC planned for RNU
HER2-positive tumor defined as IHC 1+, 2+, or 3+ on preoperative or surgical specimen testing.
ECOG performance status 0-1.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Drug: Disitamab Vedotin
Treatment groups
49 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov