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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Participants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy.
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
12-Month Intravesical Recurrence Rate
Proportion of participants with histologically confirmed bladder urothelial recurrence within 12 months after radical nephroureterectomy.
Time frame: 12 months
Intravesical Recurrence-Free Survival (IVRFS)
Time from radical nephroureterectomy to first histologically confirmed bladder recurrence.
Time frame: Up to 24 months
Cumulative Incidence of Bladder Recurrence
Cumulative incidence of bladder recurrence with distant metastasis or death treated as competing events.
Time frame: 12 months, 24 months
Metastasis-Free Survival (MFS)
Time from radical nephroureterectomy to distant recurrence or death from any cause.
Time frame: Up to 24 months
Safety and Tolerability
Incidence, type, and severity of adverse events graded according to CTCAE version 5.0.
Time frame: From treatment to 90 days after instillation
Feasibility of Intravesical RC48 Administration
Successful completion of planned intravesical administration without premature discontinuation or procedure-related serious complication.
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.