Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShaogang Wang
About this trial
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.
Eligibility criteria
Qualifiers
Voluntarily sign an informed consent form, understand the study and are willing and able to follow and complete all trial procedures
Gender is not limited, age between 18 to 75 years old (inclusive of boundary values)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Previously confirmed non-muscle-invasive bladder cancer by imaging and pathology
Disqualifiers
The primary tumor is upper urinary tract urothelial carcinoma of the renal pelvis and ureter
Patients who have suffered from malignant tumors other than bladder urothelial carcinoma within 5 years before enrollment. However, the following patients are included (eligible for enrollment): ① Patients with locally low-risk prostate cancer (staging ≤T2b, Gleason score ≤7, and PSA ≤ 20ng/ml, with no recurrence after treatment as determined by follow-up PSA levels); ② Patients with low-risk prostate cancer (staging T1/T2a, Gleason score ≤7, and PSA ≤10ng/ml, in the observation phase without treatment; ③ Patients who meet other enrollment criteria but have very low risk of metastasis or death from malignant tumors, and who show no recurrence or metastasis after standard treatment, as confirmed by imaging and disease-specific tumor marker tests, such as fully treated carcinoma in situ of the cervix, basal or squamous cell skin cancer; in situ ductal carcinoma after treatment surgery, etc
Patients with active autoimmune diseases who have required systemic treatment (i.e., long-term use of corticosteroids or immunosuppressive drugs) within the past two years. Replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is excluded
Patients who are expected to have major surgery during the study period or who have undergone major surgery within 4 weeks before dosing and have not fully recovered
Trial design
Treatments tested in this trial
- Mitomycin C (MMC)
- Normal Saline (Placebo)
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shaogang Wang
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov