High risk non-muscular invasive bladder cancer
Conditions
Interventions
Experimental group:Each subject needs to dissolve 40mg of mitomycin in 50ml of normal saline per intensive neoadjuvant intravesical perfusion. Dosing method: Preoperative neoadjuvant intravesical perf
Control group:Each subject was given 50ml of normal saline intravesical perfusion per placebo control neoadjuvant bladder. Dosing method: Preoperative neoadjuvant intravesical perfusion is administere
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed informed consent, understand the study and are willing to follow and have the ability to complete all trial procedures; 2. Male or female, age 18~75 years old (including boundary value); 3. Patients with a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) score; 4. Prior non-muscle-invasive bladder cancer confirmed by imaging and pathology; 5. Patients with NMIBC who meet the EAU Guidelines (2024 Edition) and are classified as high-risk. All patients with T1 HG/G3 and CIS except the very 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> 3 cm); 6. Subjects are willing to provide specimens from the last cystoscopic biopsy or specimens from previous recurrent surgery (including paraffin blocks, paraffin-embedded sections, etc.); 7. The interval between the first dose of anti-tumor therapy (chemoradiotherapy, immunotherapy) received in the past is >=6 weeks from the first dose of this trial; 8. Appropriate organ function and hematopoietic function: neutrophil count (NEUT>=1.5×109/L; White blood cell count (WBC) >=3.0×109/L; Platelet count>=100×109/L; hemoglobin > = 90 g/L; serum creatinine < = 1.5 times the upper limit of normal (ULN); AST and ALT<=2.5 times ULN; serum total bilirubin <=1.5 times ULN; Activated partial thromboplastin time (APTT) <=1.5 times ULN (except for patients receiving anticoagulant therapy); 9. Male subjects must agree to use effective contraception during the treatment period and for at least 180 days after the last treatment, and not to donate sperm during this period; Women of childbearing potential must have a negative blood pregnancy test within 72 hours prior to the first neoadjuvant perfusion and agree to use effective contraception during treatment and for at least 180 days after en-bloc treatment.
Exclusion criteria
Exclusion criteria: 1. The primary tumor is upper urinary tract and ureteral urothelial carcinoma; 2. Patients with malignancies other than urothelial carcinoma of the bladder within 5 years prior to enrollment. However, the following types of patients are excluded (the following can be enrolled): Patients with locally low-risk prostate cancer (stage=2000 IU/ml, and hepatitis caused by drugs or other causes is excluded), hepatitis C (hepatitis must be positive for anti-HCV antibodies at the same time, and the HCV-RNA result is greater than the lower limit of examination); 8. Systemic diseases that are not controlled and stable after treatment, such as cardiovascular and cerebrovascular diseases, diabetes, etc.; 9. History of organ transplantation or stem cell transplantation; 10. Cardiac insufficiency (patients with grade III-IV according to NY-HA classification from the New York Heart Association); 11. Significant lung disease (e.g., shortness of breath at rest or slight activity, or the need for supplemental oxygen for any reason); 12. Before participating in the study, the investigator judged that the patient has other underlying diseases that make it impossible to use the study drug or interfere with the diagnosis of the disease, or has the potential to cause serious complications; 13. Other serious infections before administration; 14. Alcohol-dependent persons or have a history of drug abuse or drug abuse in the past year; 15. Those who have a clear history of neurological or psychiatric disorders in the past, such as epilepsy, dementia, poor compliance, or peripheral nervous system disorders; 16. Pregnant or lactating, or expected to be pregnant or give birth during the trial period; 17. Those who are known to b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Health-related quality of life;Adverse event; | — |
Countries
China
Contacts
Public ContactShaogang Wang
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed