Upper Urinary Tract Urothelial Carcinoma
Conditions
Keywords
Upper Urinary Tract Urothelial Carcinoma, Bladder Recurrence, Disitamab Vedotin, Radical Nephroureterectomy
Brief 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.
Interventions
DRUGDrug: Disitamab Vedotin
Participants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-Month Intravesical Recurrence Rate | 12 months | Proportion of participants with histologically confirmed bladder urothelial recurrence within 12 months after radical nephroureterectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intravesical Recurrence-Free Survival (IVRFS) | Up to 24 months | Time from radical nephroureterectomy to first histologically confirmed bladder recurrence. |
| Cumulative Incidence of Bladder Recurrence | 12 months, 24 months | Cumulative incidence of bladder recurrence with distant metastasis or death treated as competing events. |
| Metastasis-Free Survival (MFS) | Up to 24 months | Time from radical nephroureterectomy to distant recurrence or death from any cause. |
| Safety and Tolerability | From treatment to 90 days after instillation | Incidence, type, and severity of adverse events graded according to CTCAE version 5.0. |
| Feasibility of Intravesical RC48 Administration | Day 1 | Successful completion of planned intravesical administration without premature discontinuation or procedure-related serious complication. |
Countries
China
Contacts
CONTACTjiwei h jiwei huang
PRINCIPAL_INVESTIGATORwei xue, M.D
RenJi Hospital
Outcome results
None listed