NCT07591805Not yet recruitingPhase 2
HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC
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
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (estimated)
- First submitted
- 4 May 2026
- Start date
- 16 May 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07591805
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 49
- From 16 May 2026 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1.Evidence of metastatic disease before enrollment. 2.Prior treatment with disitamab vedotin. 3.Prior intravesical anti-cancer therapy within 12 months. 4.Active uncontrolled infection. 5.Pregnancy or breastfeeding. 6.Severe uncontrolled cardiovascular, pulmonary, hepatic, or systemic disease. 7.Known hypersensitivity to study drug components. 8.Any condition that, in the investigator's judgment, would compromise participation or interpretation.
Other
- \-
Who the study is looking for
- 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.
- No prior or concomitant bladder urothelial carcinoma within 5 years.
- Adequate hematologic, hepatic, and renal function.
- Ability to comply with protocol-required surveillance.
- Written informed consent. -
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.