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

ConditionUpper Urinary Tract Urothelial Carcinoma

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-85

SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

49 Participants

are divided into 1 treatment group

Group A: Intravesical Disitamab Vedotin Participants will receive a single postoperative intravesical instillExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

12-Month Intravesical Recurrence Rate

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

Time frame

12 months

Secondary outcomes

Intravesical Recurrence-Free Survival (IVRFS)

Time from radical nephroureterectomy to first histologically confirmed bladder recurrence.

Time frame

Up to 24 months

Cumulative Incidence of Bladder Recurrence

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

Time frame

12 months, 24 months

Metastasis-Free Survival (MFS)

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

Time frame

Up to 24 months

Safety and Tolerability

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

Time frame

From treatment to 90 days after instillation

Other outcomes

Urinary Methylation for Early Detection of Bladder Recurrence

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

Time frame

Baseline to 24 months

Tissue HER2 Expression and Clinical Outcomes

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

Time frame

Baseline to 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov

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