HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC (HERO-UTUC)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Upper Urinary Tract Urothelial Carcinoma
• Intervention / Treatment: Drug: Drug: Disitamab Vedotin

• Study Type: Interventional
• Enrollment (Estimated): 49
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: jiwei h jiwei huang; Phone Number: 8613651682825; Email: jiweihuang@outlook.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravesical Disitamab Vedotin Participants will receive a single postoperative intravesical instill; Participants will receive a single postoperative intravesical instillation of 180mg disitamab vedotin within 96 hours after radical nephroureterectomy.	Drug: Drug: Disitamab Vedotin; Participants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	Correlation of HER2 IHC level (1+/2+/3+) with recurrence endpoints.	Baseline to 24 months

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: wei xue, M.D, Renji hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 16, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Radical Nephroureterectomy; Disitamab Vedotin; Upper Urinary Tract Urothelial Carcinoma; Bladder Recurrence
• Additional Relevant MeSH Terms: disitamab vedotin
• Other Study ID Numbers: HERO-UTUC Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No