NCT07591805

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
21mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jan 2028

First Submitted

Initial submission to the registry

May 4, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

May 16, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 4, 2026

Last Update Submit

May 15, 2026

Conditions

Upper Urinary Tract Urothelial Carcinoma

Keywords

Upper Urinary Tract Urothelial CarcinomaBladder RecurrenceDisitamab VedotinRadical Nephroureterectomy

Outcome Measures

Primary Outcomes (1)

  • 12-Month Intravesical Recurrence Rate

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

    12 months

Secondary Outcomes (5)

  • Intravesical Recurrence-Free Survival (IVRFS)

    Up to 24 months

  • Cumulative Incidence of Bladder Recurrence

    12 months, 24 months

  • Metastasis-Free Survival (MFS)

    Up to 24 months

  • Safety and Tolerability

    From treatment to 90 days after instillation

  • Feasibility of Intravesical RC48 Administration

    Day 1

Other Outcomes (2)

  • Urinary Methylation for Early Detection of Bladder Recurrence

    Baseline to 24 months

  • Tissue HER2 Expression and Clinical Outcomes

    Baseline to 24 months

Study Arms (1)

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.

Drug: Drug: Disitamab Vedotin

Interventions

Drug: Disitamab VedotinDRUG

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

Intravesical Disitamab Vedotin Participants will receive a single postoperative intravesical instill

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Interventions

disitamab vedotin

Study Officials

  • wei xue, M.D

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jiwei h jiwei huang

CONTACT

8613651682825jiweihuang@outlook.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 18, 2026

Study Start

May 16, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)