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NCT Number: NCT07591805

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

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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Key information

Conditions

Upper Urinary Tract Urothelial Carcinoma

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

Drug: Disitamab Vedotin

Drug

Participants will receive a single postoperative intravesical instillation of disitamab vedotin within 96 hours after radical nephroureterectomy.

Primary outcomes

  1. 12-Month Intravesical Recurrence Rate

    Time frame: 12 months

    Proportion of participants with histologically confirmed bladder urothelial recurrence within 12 months after radical nephroureterectomy.

Secondary outcomes

  1. Intravesical Recurrence-Free Survival (IVRFS)

    Time frame: Up to 24 months

    Time from radical nephroureterectomy to first histologically confirmed bladder recurrence.

  2. Cumulative Incidence of Bladder Recurrence

    Time frame: 12 months, 24 months

    Cumulative incidence of bladder recurrence with distant metastasis or death treated as competing events.

  3. Metastasis-Free Survival (MFS)

    Time frame: Up to 24 months

    Time from radical nephroureterectomy to distant recurrence or death from any cause.

  4. Safety and Tolerability

    Time frame: From treatment to 90 days after instillation

    Incidence, type, and severity of adverse events graded according to CTCAE version 5.0.

  5. Feasibility of Intravesical RC48 Administration

    Time frame: Day 1

    Successful completion of planned intravesical administration without premature discontinuation or procedure-related serious complication.

Other outcomes

  1. Urinary Methylation for Early Detection of Bladder Recurrence

    Time frame: Baseline to 24 months

    Diagnostic performance of serial urinary methylation assays for detecting subsequent bladder recurrence.

  2. Tissue HER2 Expression and Clinical Outcomes

    Time frame: Baseline to 24 months

    Correlation of HER2 IHC level (1+/2+/3+) with recurrence endpoints.

Study contacts

Contact information is provided by the study sponsor or research team.

jiwei h jiwei huang

CONTACT

[email protected]

8613651682825

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study 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

Acronym: HERO-UTUC

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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