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

Starting soon · Phase 2

Conditions studied: Upper Urinary Tract Urothelial Carcinoma

In brief

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.

Key facts

Study ID

NCT07591805

Run by

RenJi Hospital

People needed

49

Starts

2026-05-16

Expected to finish

2028-01-31

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. -

You may not qualify if…

• 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.

Where it is running

• Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.