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Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer

NCT07756008 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-08-10

No results posted yet for this study

Summary

This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder urothelial carcinoma receiving bladder-sparing treatment. Eligible patients with HER2 expression of IHC 2+ or higher who decline radical cystectomy will be randomized 1:1 to receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection. The primary endpoint is the 2-year bladder-intact event-free survival rate. Secondary endpoints include clinical complete response, partial response, disease progression, overall survival, quality of life, safety, treatment cost, and exploratory biomarker analyses.

Conditions

  • Bladder Urothelial Carcinoma
  • Muscle-invasive Bladder Cancer
  • Bladder Cancer

Interventions

PROCEDURE

Transurethral Resection of Bladder Tumor

Maximal transurethral resection of bladder tumor will be performed as part of the bladder-sparing treatment strategy.

PROCEDURE

Pelvic Lymph Node Dissection

Standardized pelvic lymph node dissection will be performed in participants assigned to the PLND arm.

DRUG

Disitamab Vedotin (RC48)

Disitamab vedotin will be administered in combination with toripalimab according to the study protocol.

DRUG

Toripalimab

Toripalimab will be administered in combination with disitamab vedotin according to the study protocol.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Tianjin Medical University Second Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-06-20
Completion
2031-06-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07756008 on ClinicalTrials.gov