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

NCT07756008 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Medical University Second Hospital

Phase

Phase 2/3

Started

2026-08-01

Last updated

2026-08-10

Condition(s) studied

Bladder Urothelial CarcinomaMuscle-invasive Bladder CancerBladder Cancer

Investigational drug(s) / intervention(s)

Disitamab Vedotin (RC48) →Toripalimab →Transurethral Resection of Bladder TumorPelvic Lymph Node Dissection

Disitamab Vedotin (RC48): Disitamab vedotin will be administered in combination with toripalimab according to the study protocol.

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

Transurethral Resection of Bladder Tumor: Maximal transurethral resection of bladder tumor will be performed as part of the bladder-sparing treatment strategy.

Pelvic Lymph Node Dissection: Standardized pelvic lymph node dissection will be performed in participants assigned to the PLND arm.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Male or female participants aged 18 years or older. 2. Histologically confirmed bladder urothelial carcinoma. 3. Clinical stage cT2-3N0M0 according to the AJCC 8th edition TNM staging system. 4. HER2 expression of IHC 2+ or higher. 5. Participants who decline radical cystectomy as assessed by the investigator. 6. Adequate organ function as defined in the study protocol. 7. Ability to understand and willingness to sign written informed consent. Exclusion Criteria: 1. Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies. 2. Prior radiotherapy for bladder cancer. 3. Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol. 4. Pregnant or breastfeeding women. 5. Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate. 6. Participation in another interventional clinical trial that may interfere with this study.

Primary outcome measure(s)

2-year Bladder-intact Event-free Survival Rate — 24 months after randomization
The proportion of participants who remain alive with an intact bladder and without muscle-invasive bladder cancer recurrence, regional lymph node recurrence, distant metastasis, radical cystectomy, or bladder cancer-related death at 24 months after randomization.

Trial sites (1)

Facility	City	Region	Status
The Second Hospital of Tianjin Medical University	Tianjin	Tianjin Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07756008 on ClinicalTrials.gov ↗ ← All trials in China