Bladder Cancer
Conditions
Interventions
Experimental group:Intravesical hematoporphyrin perfusion photodynamic therapy+ BCG intravesical infusion therapy
Sponsors
Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 80 years, whose non-muscular invasive bladder cancer has been confirmed by histology to relapse after BCG treatment, cannot tolerate total cystectomy or have a strong desire to preserve the bladder; 2. ECOG score: 0-1 points; 3. Expected survival period >= 2 years; 4. 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; 5. 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. Those who cannot tolerate BCG treatment (cannot tolerate treatment-related side effects); 4. Those who are resistant to BCG treatment (disease persists during treatment or relapses within 3 months); 5. BCG treatment ineffective (disease persists, recurrence, staging or grading during treatment); 6. Have a history of bladder contracture or the functional bladder volume is less than 200mL; 7. Patients with severe urethral stricture that cannot be inserted into a cystoscope; 8. Those who have found other tumors of the urinary and reproductive system or other organs; 9. Those who suffer from severe coagulation function, liver and kidney function, hematopoietic dysfunction, etc. who cannot tolerate surgical treatment; 10. People with immunocompromised, acquired, or congenital immunodeficiency diseases; 11. Suffer from various mental disorders, severe cardiovascular and cerebrovascular diseases, cardiopulmonary dysfunction, etc. who cannot tolerate surgery; 12. Active infection: acute pneumonia, active tuberculosis, severe urinary tract infection; 13. Women during pregnancy and lactation; 14. Those who have participated in other clinical trials in the past 30 days; 15. In addition to the above, the investigator judged the patients as unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactTian Jun
Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed