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

NCT06696794 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Non-Muscle-Invasive Bladder Cancer (NMIBC)

Interventions

DRUG

Mitomycin C (MMC)

When administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (mitomycin) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery）

DRUG

Normal Saline (Placebo)

When administering neoadjuvant intravesical instillations, instruct the patient to lie flat on the treatment bed and cover with a waterproof pad. Disinfect the perineal area 2-3 times. Under sterile conditions, insert a catheter and drain the bladder of urine completely. Slowly instill the prepared instillation solution (Normal Saline) into the bladder. If the patient experiences pain during the instillation, stop the infusion immediately, and continue when the pain subsides. If the patient still cannot tolerate it, discontinue the instillation treatment for this session. After the medication is instilled into the bladder, the catheter can be removed immediately or left in place. Instruct the patient to hold their urine for as long as possible under suitable conditions for 2 hours, and to change positions intermittently while the medication is retained in the bladder. The neoadjuvant intravesical instillation cycle is twice (one day and 4 h before en-bloc surgery）

Sponsors & Collaborators

  • Shaogang Wang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2027-06-30
Completion
2031-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06696794 on ClinicalTrials.gov