bladder cancer
Conditions
Interventions
Sponsors
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 90 years old; 2. ECOG 0-2 3. Subjects need to undergo TURBT and imaging diagnosis,and judged by investigator as MIBC (urothelial carcinoma is the main pathological component >50%), and plans to undergo radical cystectomy+ Lymph node dissection + urinary diversion; 4. Clinical staging T2-T4aN0-1M0 (can be CT/MRI/PET-CT), If the clinical stage is T2-4aN2-3M0, it needs to be judged by the investigator. If it is judged that radical surgery can still be performed, it can be included in the study 5. There are residual tumor lesions after TURBT (investigator's judgment) 6. TURBT tissue examination specimens can be provided for molecular subtype diagnosis; 7. Estimated survival period >=3 months; 8. The main organ functions are normal (14 days before enrollment), that is, meet the following criteria: 1) Routine blood examination standards must meet (no blood transfusion and no treatment with granulocyte colony stimulating factor within 14 days before enrollment): HB>=70 g/L; ANC>=1.0x10^9/L; PLT>=80x109/L; 2) Non-functional organic diseases, which must meet the following standards: T-BIL 20ml/min (Cockcroft-Gault formula); International normalized ratio (INR), activated partial thromboplastin time (aPTT): <=1.5 ULN (this standard is only applicable to patients who have not received anticoagulation therapy; patients receiving anticoagulation therapy should make anticoagulants in Within the scope of treatment requirements); 9. Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. HIV positive; 3. Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, uncontrollable diabetes, and cardiovascular disease (as defined by the New York Heart Association classification Grade III or IV heart failure, heart block above II degree, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or lung disease ( History of interstitial pneumonia, obstructive lung disease and symptomatic bronchospasm); 4. Have previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 5. Those who have a history of psychotropic drug abuse and cannot be quit or have a history of mental disorders; 6. A large amount of pleural fluid or ascites accompanied by clinical symptoms or requiring symptomatic treatment; 7. Other malignant tumors in the past 5 years have not been cured, but excluding malignant tumors that have been obviously cured, or curable cancers, such as basal skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, cervical in situ Cancer or breast carcinoma in situ; Remarks: Localized low-risk prostate cancer (defined as patients with stage <=T2c, Gleason score <=7 and PSA <=20ng/mL at the time of prostate cancer diagnosis (as measured) who have received radical treatment And those without biochemical recurrence of prostate specific antigen (PSA) can participate in this study); 8. Combined with urothelial carcinoma of upper urinary tract (urinary pelvis, ureteral urothelial carcinoma) 9. Any other severe, acute or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks , or may interfere with the interpretation of the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC area, sensitivity and specificity of pathological complete response rate after radical operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC area, sensitivity, and specificity of pathological partial response;The area, sensitivity and specificity of AUC benefiting from disease-free surviva;DNA profile;IHC;RNA profile; | — |
Countries
China
Contacts
Public ContactHaige Chen
Department of Urology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed