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.
Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma.
Upper urinary tract urothelial carcinoma requiring treatment.
Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components.
Active uncontrolled urinary tract infection.