NCT07747740RecruitingPhase 2
Sequential Gemcitabine Plus Docetaxel Versus Gemcitabine Plus Mitomycin C for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- First submitted
- 31 Jul 2026
- Start date
- 9 Jul 2026
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Diseases
- Bladder cancer
- NCT number
- NCT07747740
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 228
- From 9 Jul 2026 to the primary completion date, 30 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous hypersensitivity to gemcitabine, docetaxel, mitomycin C, or formulation components.
- Concurrent participation in another interventional clinical trial.
Other illness
- Active uncontrolled urinary tract infection.
- Any serious uncontrolled medical condition that, in the investigator's opinion, would interfere with study participation or interpretation of results.
Other
- Muscle-invasive (≥T2), locally advanced, or metastatic urothelial carcinoma.
- Upper urinary tract urothelial carcinoma requiring treatment.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| N.N.Blokhin National Medical Research Center of Oncology Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.