NCT07756008Not yet recruitingPhase 2/3
Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer
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
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 27 Jun 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 20 Jun 2029
- Lead sponsor
- Tianjin Medical University Second Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07756008
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 114
- From 1 Aug 2026 to the primary completion date, 20 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy for bladder cancer.
- Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol.
Other illness
- 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.
Other
- Pregnant or breastfeeding women.
- Participation in another interventional clinical trial that may interfere with this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.