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NCT06696794

Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients

Recruiting now Phase 3 Last updated 19 February 2025
What this trial tests

Phase 3 trial testing Mitomycin C (MMC) in Non-Muscle-Invasive Bladder Cancer (NMIBC) in 180 participants. Currently enrolling.

Timeline
17 February 2025
Primary endpoint
30 June 2027
30 June 2031

Quick facts

Lead sponsorShaogang Wang
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment180
Start date17 February 2025
Primary completion30 June 2027
Estimated completion30 June 2031
Sites3 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Shaogang Wang

Who can join

Adults 18 to 75, any sex, with Non-Muscle-Invasive Bladder Cancer (NMIBC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Mitomycin C (MMC)

Trials testing the same drug.

Other recruiting trials for Non-Muscle-Invasive Bladder Cancer (NMIBC)

Currently open trials in the same condition.

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Data sources for this page

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