Disitamab vedotin and toripalimab for bladder cancer, with or without lymph node removal
Tests whether removing pelvic lymph nodes helps when treating bladder cancer without removing the bladder.
Plain-language title generated from the registry record
Registry title: Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2/3
Where in China
- The Second Hospital of Tianjin Medical UniversityTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Medical University Second Hospital
- Trial code
- NCT07756008
- Record updated
- 10 August 2026
- Original description
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.Read full original descriptionShow less
A Prospective, Multicenter, Randomized Controlled Study of Disitamab Vedotin Plus Toripalimab With or Without Pelvic Lymph Node Dissection for Bladder-Sparing Treatment in Patients With cT2-3N0M0 Bladder Urothelial Carcinoma
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.
Inclusion: Male or female participants aged 18 years or older; Histologically confirmed bladder urothelial carcinoma; Clinical stage cT2-3N0M0 according to the AJCC 8th edition TNM staging system; HER2 expression of IHC 2+ or higher; Participants who decline radical cystectomy as assessed by the investigator; Adequate organ function as defined in the study protocol; Ability to understand and willingness to sign written informed consent.
Exclusion: Prior radiotherapy for bladder cancer; Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol; Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies; Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate; Pregnant or breastfeeding women; Participation in another interventional clinical trial that may interfere with this study.