Bladder cancer
Conditions
Interventions
Treatment Group:Preoperative injection of sintilimab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria for inclusion: 1. The subject is willing and able to provide written informed consent to abide by the agreement; 2. Aged >= 18 years; 3. The transitional cell carcinoma of the bladder was confirmed by histopathology. Patients with mixed histology need to be > 50% urothelial carcinoma; 4. Cystectomy is appropriate and planned (according to guidelines); 5. T2-t3bn0m0 patients assessed by CT, MRI or PET / CT (4 weeks before enrollment); 6. After the initial TURBT, there were still tumor remains (surgical opinion, cystoscopy or imaging); 7. It can provide a representative formalin fixed paraffin embedded (FFPE) bladder tumor sample, more than 15 white films, and has relevant pathological reports, which can be used to detect the expression level of PDL1. When the white film is more than 10 but less than 15, it needs to be associated with the Department of pathology of Fudan University Affiliated Tumor Hospital to detect the expression of PDL1; 8. The status of ECoG was 0 or 1; 9. Sufficient hematology and end organ function within 4 weeks before the first study treatment, as follows: (1) Neutrophils >= 1500 cells / µ L (no granulocyte colony stimulating factor support in the first cycle, 2 weeks before the first day); (2) Lymphocyte count >= 500 / µ L; (3) Platelet count >= 10000 / µ L (no blood transfusion within 2 weeks before day 1, cycle 1); (4) Hemoglobin >=9.0g/dl (patients can receive blood transfusion or erythropoiesis therapy to meet this standard); (5) Ast or alt, ALP = 20ml / min (Cockcroft Gault formula). 10. Women should agree to use contraceptive measures (such as IUD, contraceptive or condom) during the study period and within 6 months after the end of the study; women should be negative in serum or urine pregnancy test within 7 days before the study group, and must be non lactating patients; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period. 11. The subjects were required to give informed consent to the study before the trial, and signed the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: Patients meeting one or more of the following criteria will be excluded: 1. Pregnant and lactating women. Blood ß - hCG was found to be positive in fertile female subjects 2 weeks before admission. 2. Long term oral administration of steroids, methylprednisolone or its analogues over 10 mg / day, must be stopped for 28 days before entering the group. 3. Patients with bladder cancer who have received systemic chemotherapy before. Patients with bladder cancer who had previously received radiotherapy or concurrent radiotherapy and chemotherapy can be enrolled. 4. Malignant tumors other than UBC in the five years before the first day of the first cycle, except for those patients with negligible risk of metastasis or death and receiving the expected outcome (such as cervical, basal or squamous cell in situ full treatment), skin cancer, or ductal carcinoma in situ, curative surgery or local prostate cancer treatment, treatment intention and no prostate specific antigen (PSA )Recurrent or incidental prostate cancer (Gleason score <= 3 + 4, PSA < 10 ng / ml for active monitoring and treatment). 5. There are measurable lymph nodes or distant metastases. 6. Evidence of significantly uncontrolled concomitant diseases may affect the interpretation of protocol compliance or outcomes, including significant liver diseases (such as cirrhosis, uncontrolled major seizures, or superior vena cava syndrome). 7. Major cardiovascular diseases, such as New York Heart Association heart disease (grade II or higher), myocardial infarction within 3 months before enrollment, unstable arrhythmia or unstable angina. 8. Severe infection occurred within 4 weeks before enrollment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. 9. Diagnostic procedures such as TURBT or biopsy were not included for patients who underwent major surgery within 4 weeks prior to enrollment or who were expected to require major surgery during the course of the study. 10. Patients receiving therapeutic oral or intravenous (IV) antibiotics (prophylactic antibiotics (for example, for the prevention of urinary tract infection or chronic obstructive pulmonary disease) within 14 days before enrollment can be enrolled. 11. Previously, it was used for intravenous chemotherapy of bladder cancer. 12. Patients with previous allogeneic stem cell or solid organ transplants. 13. Previously, CD137 agonists, anti-CTLA-4, anti programmed death-1 (PD-1) or anti-PD-L1 therapeutic antibodies or pathway targeting agents were used. 14. Patients should not take steroids orally or intravenously within 14 days before entering the study. Inhaled corticosteroids, physiologically alternative doses of glucocorticoids (i.e., adrenal insufficiency) and corticosteroids (e.g., hydrocortisone) are permitted. 15. Patients who have received organ transplantation or allogeneic stem cell transplantation in the past. 16. Live attenuated vaccine was given within 4 weeks prior to registration or is expected to be required during the study. 17. Prior to registration, treatment with systemic immune stimulants (including, but not limited to, interferon or interleukin [IL] - 2) for 4 weeks or 5 half lives of the drug, whichever is shorter. 18. Within 4 weeks prior to enrollment, they were treated with any other study drug or participated in another clinical trial with therapeutic intention. 19. The history of idiopathic pulmonary fibrosis (including pneum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event rate;relapse free survival;overall survival;Incidence of surgical related delayed events;Number of patients undergoing cystectomy 12 weeks after treatment; | — |
Countries
China
Contacts
Public ContactYe Dingwei
Shanghai Cancer Center affiliated to Fudan University
Outcome results
None listed