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

Sponsor
Tianjin Medical University Second Hospital
Study ID
NCT07756008
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Disitamab Vedotin (RC48) — DRUG
    Disitamab vedotin will be administered in combination with toripalimab according to the study protocol.
  • Toripalimab — DRUG
    Toripalimab will be administered in combination with disitamab vedotin according to the study protocol.
  • Transurethral Resection of Bladder Tumor — PROCEDURE
    Maximal transurethral resection of bladder tumor will be performed as part of the bladder-sparing treatment strategy.
  • Pelvic Lymph Node Dissection — PROCEDURE
    Standardized pelvic lymph node dissection will be performed in participants assigned to the PLND arm.

Study Details

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 Dates

First listed
Aug 10, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Jun 20, 2029
Completion
Jun 20, 2031

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection
    Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab and standardized pelvic lymph node dissection.
  • Active Comparator: Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection
    Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab without planned pelvic lymph node dissection.

Primary Outcome Measure

2-year Bladder-intact Event-free Survival Rate [ Time Frame: 24 months after randomization ]

Central Contacts

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