HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug: Disitamab Vedotin.
- Who it may be relevant to
- Registry conditions: Upper Urinary Tract Urothelial Carcinoma. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Phase II Study of Single Postoperative Intravesical Disitamab Vedotin to Prevent Bladder Recurrence After Radical Nephroureterectomy in HER2-Positive Upper Tract Urothelial Carcinoma
Overview
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
- Drug Drug: Disitamab Vedotin
Participants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy.
Primary outcome measures
- 12-Month Intravesical Recurrence Rate [Time frame: 12 months]
Secondary outcome measures (5)
- Intravesical Recurrence-Free Survival (IVRFS) [Time frame: Up to 24 months]
- Cumulative Incidence of Bladder Recurrence [Time frame: 12 months, 24 months]
- Metastasis-Free Survival (MFS) [Time frame: Up to 24 months]
- Safety and Tolerability [Time frame: From treatment to 90 days after instillation]
- Feasibility of Intravesical RC48 Administration [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- 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. -
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.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT07591805 · HERO-UTUC Trial