Drug: Disitamab Vedotin: Participants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years.
2. Histologically or radiologically suspected UTUC planned for RNU
3. HER2-positive tumor defined as IHC 1+, 2+, or 3+ on preoperative or surgical specimen testing.
4. ECOG performance status 0-1.
5. No prior or concomitant bladder urothelial carcinoma within 5 years.
6. Adequate hematologic, hepatic, and renal function.
7. Ability to comply with protocol-required surveillance.
8. Written informed consent. -
Exclusion Criteria:
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.
\-
Primary outcome measure(s)
12-Month Intravesical Recurrence Rate — 12 months Proportion of participants with histologically confirmed bladder urothelial recurrence within 12 months after radical nephroureterectomy.
Trial sites (1)
Facility
City
Region
Status
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.