Carcinoma of urinary bladder
Conditions
Interventions
Case series:TURBt+PDT
Sponsors
National Cancer Center /National Clinical Research Center for Cancer /Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old, male or female; Within 3 months prior to enrollment, cystoscopy, histology, and/or cytopathology confirmed a diagnosis of moderate to high risk non-muscle invasive bladder urothelial carcinoma, including: 1) Recurrent, refractory NMIBC: Recurrent NMIBC (number of relapses = 2); CIS and T1G3 tumors were ineffective after TURBT and bladder infusion therapy; 2) Middle-risk and high-risk NMIBC: Medium risk NIMBC; Does not meet the low-risk and high-risk NIMBC conditions; High-risk NIMBC: Meet one of the following conditions: T1 tumor; G3 (high-grade) tumors; CIS. At the same time consistent with: multiple low-grade (G1-2) tumors of Ta, with a diameter of >3cm Low-risk NIMBC: All the following conditions are met: primary, single, Ta, G1 (low level), diameter <3cm, no CIS. 2. ECOG score: 0-1 points; 3. Expected survival period = 2 years; Voluntarily participate in this test and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with muscle invasive bladder urothelial carcinoma (stage T2 and above); 2. had a history of bladder contracture or functional bladder volume less than 200mL; 3. severe urethral stricture can not be placed cystoscopy; 4. Pelvic CT or full physical examination found tumor metastasis; 5. With other urogenital tumors (such as upper urinary tract cancer patients (UTUC), etc.) or other tumors; 6. People with inherited or acquired coagulopathy or who are taking anticoagulant drugs; 7. There are obvious major internal organs dysfunction, such as: creatinine> 1.5 times the upper limit of the normal range, AST, ALT, total bilirubin> 1.5 times the upper limit of normal range; 8. Decrease of bone marrow hematopoietic function: Subjects have white blood cells < 3.0×10^9/L, or hemoglobin less than 80 g/L, or neutrophils <1.5×10^9/L, or platelets <75×10^9/L, or others People with blood system diseases; 9. Known immunocompromised, acquired, congenital immunodeficiency, or history of organ transplantation; 10. There is a tumor center metastasis or invasion or various mental disorders; 11. Severe cardiovascular and cerebrovascular diseases, such as myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism Those who cannot tolerate TURBT surgery; 12. Uncontrolled hypertensive patients (systolic blood pressure =180mmHg, diastolic blood pressure =110mmHg), severe complications of hypertension, or severe complications of diabetes after intervention therapy; 13. The fever body temperature exceeds 38°C, there are obvious active infections that may affect clinical trials such as acute pneumonia, active tuberculosis, severe urinary tract infection subjects, etc.; 14. Pregnant, lactating women, or subjects that are judged to be not using adequate contraceptive measures, including male subjects; 15. Have participated in other clinical trials in the past 30 days; In addition to the above, the investigators determined that they were not suitable for the patients enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate;Relapse free survival; | — |
Countries
China
Contacts
Public ContactTian Jun
National Cancer Center /National Clinical Research Center for Cancer /Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed