Bladder Cancer
Conditions
Interventions
PDT+Mitomycin(RCT):PDT+Mitomycin
PDT(RCT):PDT
Mitomycin(RCT):Mitomycin
PDT+Mitomycin(single-arm):PDT+Mitomycin
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patient aged 18-80 years, and confirmed by histology as high-risk non-muscular invasive bladder cancer. 2. ECOG score: 0-1 points; 3. Complete screening related examinations (blood routine, coagulation function, liver and kidney function, infectious disease screening, 12-lead electrocardiogram, urinary system B-ultrasound, pelvic enhanced CT or MR, histopathological examination), and no surgical contraindications; 4. Volunteer to participate in this trial and sign an informed consent form;
Exclusion criteria
Exclusion criteria: 1. Patients with muscular invasive bladder urothelial carcinoma (T2 stage and above); 2. Those who are known to be allergic to test drugs or related drugs; 3. Have a history of bladder contracture or the functional bladder volume is less than 100mL; 4. Patients with severe urethral stricture that cannot be inserted into a cystoscope; 5. Other tumors of the genitourinary system or other organs are found during the inspection; 6. Those who suffer from severe coagulation function, liver and kidney function, hematopoietic dysfunction, etc. who cannot tolerate surgical treatment 7. Those who suffer from immunocompromised, acquired, or congenital immunodeficiency diseases; 8. Suffering from various mental disorders, severe cardiovascular and cerebrovascular diseases, cardiopulmonary dysfunction, etc. who cannot tolerate surgery; 9. There are active infections: acute pneumonia, active tuberculosis, severe urinary tract infection; 10. Women during pregnancy and lactation; 11. Participated in other clinical trials in the past 30 days; 12. Patients judged by the investigator as unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival, RFS;Complete remission, CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month and 12-month recurrence free survival;Safety endpoints;quality of life;Objective relief rate;Disease progression rate;Bladder function score; | — |
Countries
China
Contacts
Public ContactXiang Wang
Shanghai General Hospital
Outcome results
None listed