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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06696794 currently recruiting?
Yes, this trial is currently recruiting patients.
What disease stage is eligible?
Stage T1 HG/G3 or CIS or TA LG/G2 or T1G1 or TA HG/G3 or T1 LG or T1G2 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages