Non muscle-invasive bladder cancer
Conditions
Interventions
Test group:photodynamics therapy
Control group:Epirubicin intravesical infusion chemotherapy
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years old; 2) ECOG score: 0-1 points; 3) Expected survival period >= 2 years; 4) Patients who underwent transurethral resection of bladder tumors were pathologically diagnosed with urothelial carcinoma; 5) The postoperative specimen contains the intrinsic muscle layer (detrusor muscle); 6) Postoperative specimens were pathologically confirmed as non muscle invasive bladder cancer, and TNM staging was Ta-1N0M0; 7) Patients with EORTC recurrence score ranging from 1 to 9; 8) There has been no previous allergy to photosensitizers, epirubicin, or similar ingredients; 9) Can tolerate bladder infusion therapy; 10) Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Pathological diagnosis of bladder tumor after transurethral resection combined with focal squamous cell carcinoma, micropapillary carcinoma and other pathological variations; 2) The pathological diagnosis after transurethral resection of bladder tumors is difficult, and patients with tumor muscle layer infiltration cannot be ruled out; 3) Due to reasons such as inability to cooperate, difficulty tolerating infusion therapy, and difficulty tolerating cystoscopy, patients who were unable to undergo regular follow-up examinations were included in the study and were followed up for less than 1 year without clear tumor recurrence or progression; 4) Patients who switch to other treatments without clear evidence of tumor recurrence or progression; 5) Patients who participate in other non observational clinical trials after inclusion in the study; 6) Individuals with hereditary or acquired coagulation disorders or those currently using anticoagulant drugs; 7) There are obvious dysfunction of major internal organs, such as creatinine>1.5 times the upper limit of the normal range, ASTALT Total bilirubin>1.5 times the upper limit of the normal range, etc; 8) Reduced bone marrow hematopoietic function: subjects with white blood cells= 180mmHg, diastolic pressure >= 110mmHg) that has not been controlled after intervention treatment, or severe complications of hypertension, or severe complications of diabetes; 12) Subjects with fever and body temperature exceeding 38 ?, as well as active infections such as acute pneumonia, active tuberculosis, and severe urinary tract infections that may affect clinical trials; 13) Pregnant or lactating women, or subjects judged to have not used sufficient contraceptive measures, including male subjects; 14) The researchers believe that it is not appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence rate after surgery; | — |
Countries
China
Contacts
Public ContactTian Jun
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
Outcome results
None listed