Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer

Recruiting now · Phase 2

Conditions studied: Non-Muscle-Invasive Bladder Cancer, BCG-Unresponsive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT07747740

Run by

Blokhin's Russian Cancer Research Center

People needed

228

Starts

2026-07-09

Expected to finish

2030-12-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Pregnancy or breastfeeding.
• Concurrent participation in another interventional clinical trial.
• Any serious uncontrolled medical condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.

Where it is running

• N.N. Blokhin National Medical Research Center of Oncology — Moscow, Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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