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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravesical Disitamab Vedotin Participants will receive a single postoperative intravesical instill | Experimental | Participants will receive a single postoperative intravesical instillation of 180mg disitamab vedotin within 96 hours after radical nephroureterectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Disitamab Vedotin | Drug | Participants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12-Month Intravesical Recurrence Rate | Proportion of participants with histologically confirmed bladder urothelial recurrence within 12 months after radical nephroureterectomy. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intravesical Recurrence-Free Survival (IVRFS) | Time from radical nephroureterectomy to first histologically confirmed bladder recurrence. | Up to 24 months |
| Cumulative Incidence of Bladder Recurrence |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Methylation for Early Detection of Bladder Recurrence | Diagnostic performance of serial urinary methylation assays for detecting subsequent bladder recurrence. | Baseline to 24 months |
| Tissue HER2 Expression and Clinical Outcomes |
Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jiwei h jiwei huang | Contact | 8613651682825 | jiweihuang@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| wei xue, M.D | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| C000722994 | disitamab vedotin |
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Cumulative incidence of bladder recurrence with distant metastasis or death treated as competing events.
| 12 months, 24 months |
| Metastasis-Free Survival (MFS) | Time from radical nephroureterectomy to distant recurrence or death from any cause. | Up to 24 months |
| Safety and Tolerability | Incidence, type, and severity of adverse events graded according to CTCAE version 5.0. | 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. | Day 1 |
Correlation of HER2 IHC level (1+/2+/3+) with recurrence endpoints.
| Baseline to 24 months |