A Prospective, Randomized, Open-Label, Phase II Trial Comparing Sequential Intravesical Gemcitabine Plus Docetaxel With Sequential Intravesical Gemcitabine Plus Mitomycin C in Patients With BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
This prospective, randomized, open-label, phase II clinical trial compares two sequential intravesical chemotherapy regimens in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) following complete transurethral resection of bladder tumor (TURBT). Participants are randomized in a 1:1 ratio to receive sequential intravesical gemcitabine plus docetaxel or sequential intravesical gemcitabine plus mitomycin C. The primary objective is to compare 12-month event-free survival between treatment groups. Secondary objectives include evaluation of cystectomy-free survival, progression-free survival, treatment safety, tolerability, and patient-reported quality of life.
• Age ≥18 years.
• Histologically confirmed BCG-unresponsive non-muscle-invasive urothelial bladder cancer (NMIBC).
• Complete transurethral resection of bladder tumor (TURBT) before study treatment.
• Intermediate- or high-risk NMIBC according to current clinical guidelines.
• Candidate for intravesical chemotherapy.
• ECOG performance status 0-2.
• Adequate hematologic, renal, and hepatic function.
• Written informed consent.