Bladder cancer
Conditions
Interventions
DTBF 5 mg/kg group:DTBF 5 mg/kg, intravenous drip
DTBF 7.5 mg/kg group:DTBFDTBF7. 5 mg/kg, intravenous drip
pre-test group:DTBFDTBF7. 5 mg/kg, intravenous drip
Sponsors
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Males and females aged 18-75 years; 2) Primary or relapsed non-muscle invasive bladder cancer (Ta or T1) histopathologically diagnosed within 3 months; 3) With a single tumor larger than 1 cm or multiple bladder tumors; 4) Without severe hematological disease, heart, lung, liver or renal impairment; 5) ECOG score 0-1; 6) The patient or legal guardian signs written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Imaging examination indicates muscle involvement of bladder tumor or indication of cystectomy; 2) A history of bladder contracture or functional bladder volume less than 200 mL; 3) Pelvic CT scan or complete physical examination reveals tumor metastasis; 4) Previous photodynamic therapy or radiotherapy on bladder; 5) Allergic constitution; present allergic disease; patients with skin photosensitivity disorders, porphyria or a history of allergy to the investigational drug (porphyrins) or drugs with similar chemical structure; 6) Use of known photosensitive drugs within 1 month, such as tetracycline, sulfonamides, phenothiazine, sulfonylurea hypoglycemic drugs, thiazide diuretics, retinoic acids and griseofulvin; 7) Patients with inherited or acquired coagulation disorder or using anticoagulants; 8) With significant vital organ dysfunction, such as creatinine more than 1.5 times upper limit of normal, AST, ALT and total bilirubin more than 1.5 times upper limit of normal, or fasting blood glucose more than 8 mmol/L; 9) Impaired bone marrow hematopoietic function: white blood cell count less than 4.0×109/L, neutrophil count less than 1.5×109/L, platelet count less than 100×109/L; hemoglobin less than 90 g/L; 10) Immunocompromised condition, acquired or congenital immunodeficiency disorder, or a history of organ transplantation; 11) CNS tumor metastasis or invasion, or various mental disorders; 12) Serious cardio- and cerebrovascular diseases, such as myocardial infarction, cerebrovascular accident and heart failure; 13) Fever with body temperature higher than 38?, or significant active infection that may influence the clinical trial; 14) Pregnant and nursing women, or subjects considered not using sufficient contraceptive measures, including male subjects; 15) Patients participating in another clinical trial in the past 30 days; 16) Patients considered by investigators to have poor compliance due to medical or non-medical factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| drug concentrations in tumor tissue and normal tissues at different time points after administration;physical examination and vital signs; laboratory examination; ECG; adverse events; | — |
Countries
China
Contacts
Public ContactZhangqun Ye, Xiaodong Song
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed