Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy for Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer

StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

  1. Study First Submitted
This randomized controlled trial aims to evaluate the efficacy and safety of antibody-drug conjugate (ADC) plus immunotherapy compared with immunotherapy plus chemotherapy in patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC). Patients will be randomly assigned to receive either ADC plus immunotherapy or immunotherapy plus chemotherapy. The study will assess the effectiveness of these two treatment strategies in achieving complete response, maintaining disease control, and preserving the bladder, as well as their safety and tolerability. The findings may help identify an effective bladder-preserving treatment strategy for patients with extensive very-high-risk NMIBC who cannot undergo complete transurethral resection.
Trial Details
NCT Number NCT07879469
Lead Sponsor Tianjin Medical University Second Hospital
Conditions
(from sponsor)
Bladder (Urothelial, Transitional Cell) Cancer, Antibody-drug Conjugates, Immunotherapy, Chemotherapy, Systemic Therapy
Related terms Neoplasms
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov