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

Starting soon · Phase 2/Phase 3

Conditions studied: Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer, Bladder Cancer

In brief

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.

Key facts

Study ID

NCT07756008

Run by

Tianjin Medical University Second Hospital

People needed

114

Starts

2026-08-01

Expected to finish

2031-06-20

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies.
• Prior radiotherapy for bladder cancer.
• Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol.
• Pregnant or breastfeeding women.
• Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate.
• Participation in another interventional clinical trial that may interfere with this study.

Where it is running

• The Second Hospital of Tianjin Medical University — Tianjin, Tianjin Municipality, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.