Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?

Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with transurethral resection of bladder tumor (TURBT). However, the optimal duration of systemic immunotherapy after achieving a tumor-free status remains uncertain. Prolonged treatment may increase toxicity, treatment burden, and cost, while some patients may maintain durable disease control without continued therapy. This randomized study aims to evaluate whether active surveillanc

Trial Details

NCT ID
NCT07625527
Phase
PHASE2
Sponsor
Tianjin Medical University Second Hospital
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Active Surveillance
  • PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy
Locations (sample)
  • Tianjin, China|39.14222,117.17667
  • Tianjin, China|39.14222,117.17667
  • Tianjin, China|39.14222,117.17667
  • Xingtai, China|37.06217,114.49272

Key Eligibility Criteria

  • Has histologically confirmed very-high-risk non-muscle-invasive urothelial carcinoma of the bladder.
  • Has transurethrally unresectable bladder tumor, defined as visually incomplete TURBT and/or extensive high-volume disease considered unsuitable for…
  • Has undergone cystoscopy and TURBT evaluation before study enrollment.
  • Has received systemic PD-1/PD-L1 inhibitor-based bladder-sparing therapy before randomization.

For full eligibility, visit ClinicalTrials.gov.

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