Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer

This study evaluates whether urinary tumor DNA (utDNA) testing, together with clinical, pathologic, and radiographic assessment, can help guide treatment discontinuation and active surveillance in patients with unresectable very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) treated with bladder-sparing systemic immunotherapy. Participants receive systemic immune checkpoint inhibitor-based therapy every 3 weeks for an initial 3 cycles. Initial response assessment is performed using transurethral resection of bladder tumor (TURBT) and chest and abdominopelvic computed tomography (CT)

Trial Details

NCT ID
NCT07475403
Phase
PHASE2
Sponsor
Tianjin Medical University Second Hospital
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • Systemic immunotherapy
Locations (sample)
  • Tianjin, China|39.14222,117.17667
  • Tianjin, China|39.14222,117.17667
  • Xingtai, China|37.06217,114.49272

Key Eligibility Criteria

  • Age ≥18 years.
  • Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder classified as very-high-risk (VHR) according to EAU 2025 guideline…
  • Disease considered unresectable by the investigator and multidisciplinary team, defined as complete tumor eradication by standard transurethral res…
  • Patients who are ineligible or refuse for radical cystectomy, after discussion with the treating team.

For full eligibility, visit ClinicalTrials.gov.

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