OncoMatch/Clinical Trials/NCT06696794
Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
Is NCT06696794 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Mitomycin C (MMC) for non-muscle-invasive bladder cancer (nmibc).
Treatment: Mitomycin C (MMC) — The goal of this clinical trial is to learn if neoadjuvant intravesical instillation of mitomycin C combined with en-bloc surgery works to treat high-risk non-muscle-invasive bladder cancer (NMIBC) patients. It will also learn about the safety of neoadjuvant intravesical instillation of mitomycin C. The main questions it aims to answer are: Does neoadjuvant intravesical instillation of mitomycin C heighten the 1-year recurrence-free survival (RFS) rate for high-risk non-muscle-invasive bladder cancer (NMIBC) patients? What medical problems do participants have when taking neoadjuvant intravesical instillation of mitomycin C? Researchers will compare neoadjuvant intravesical instillation of mitomycin C to a placebo (normal saline) to see if neoadjuvant intravesical instillation of mitomycin C works to treat high-risk NMIBC. Participants will: Take neoadjuvant intravesical instillation of mitomycin C or a placebo twice，1 day and 4 hours before en-bloc surgery Visit the clinic once every 8 weeks for checkups and tests Keep track of the recurrence and progression of the tumor.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage T1 HG/G3, CIS, TA LG/G2, T1G1, TA HG/G3, T1 LG, T1G2 (EAU Guidelines (2024 edition))
In accordance with the "EAU Guidelines (2024 edition)" high-risk NMIBC patient danger grouping. All T1 HG/G3 and CIS patients except for the extremely high-risk group; Ta LG/G2 or T1G1, non-CIS with three risk factors; Ta HG/G3 or T1 LG, non-CIS with at least two risk factors; T1G2 non-CIS with at least one risk factor. (Risk factors: age > 70 years; multiple papillary tumors; tumor diameter > 3cm)
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
neutrophil count (neut ≥ 1.5 × 10^9/l; white blood cell count (wbc) ≥ 3.0 × 10^9/l; platelet count ≥ 100 × 10^9/l; hemoglobin ≥ 90g/l
Kidney function
serum creatinine ≤ 1.5 times the upper limit of normal (uln)
Liver function
ast and alt ≤ 2.5 times uln; serum total bilirubin ≤ 1.5 times uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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