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

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.

NCT Number	NCT07756008
Lead Sponsor	Tianjin Medical University Second Hospital Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital with Nanjing Medical University
Conditions	Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer, Bladder Cancer
Enrollment	114 participants
Start Date	2026-08-01
Primary Completion	2029-06-20 (estimated)
Study Completion	2031-06-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-10