Muscle invasive bladder cancer
Conditions
Interventions
Experimental group: Investigate bladder-preserving regimens :None
Sponsors
The Fifth People's Hospital of Shanghai,Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.= 18-year-old male or female; 2.People who are willing to protect their bladder; 3.ECOG PS: 0 to 2 points; 4.Subjects undergo TURBT and imaging diagnosis, which the researchers judged to be muscle-invasive bladder urothelial carcinoma (receiving histological variations, not receiving diffuse CIS lesions), simple or mixed (urinary intestinal carcinoma = 50%) 5.Accept maximized TURBT 6.Clinical stages T2, N0, M0 7.Na?ve populations that have not received systemic chemotherapy or immunotherapy 8.Cisplatin tolerates people 9.Normal functioning of the main organs (14 days before enlistment) i.e. complies with the following criteria: (1) The blood routine examination criteria should be met (no blood transfusion and no granulocyte colony stimulator treatment within 14 days before admission): HB=90 g/L ANC=1.5×109 /L PLT=100×109 /L (2) Non-functional organic diseases, which must meet the following standards: T-BIL= 1.5 × ULN (upper limit of normal value); ALT and AST = 2.5 × ULN; If liver metastases, ALT and AST = 5× ULN; Estimated glomerular filtration rate (eGFR) >60 ml/min (MdRD formula); International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT): = 1.5× ULN (this criterion applies only to patients who have not received anticoagulation; Patients receiving anticoagulation should keep the anticoagulant within the limits of the therapeutic requirements); 10.Men with reproductive capacity or women with the possibility of becoming pregnant must use highly effective contraceptive methods (e.g., oral contraceptives, intrauterine devices, libido abstinence or barrier contraception in combination with spermicide) during the trial and continue contraception for 12 months after the end of treatment; 11.Participants voluntarily joined the study, signed informed consent forms, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous treatment against PD-1, anti-PD-L1, and anti-PD-L2; 2. Those who are known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 3. Those who have received other anti-tumor therapy (including but not limited to corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks prior to the start of the study treatment, or have not recovered from the previous toxicity (except for 2 degree hair loss and 1 degree neurotoxicity); 4. Pregnant or lactating women, as well as women who wish to have children (pelvic radiation therapy may cause premature ovarian failure); 5. Positive HIV test result; 6. Patients with active hepatitis B or C 7. HBsAg or HBcAb positive also detects positive HBV DNA copies (quantitative test limit is 500 IU/ml, or the copy number positive value detected by the research center is reached); HBV DNA must be detected for study screening in such patients; 8. Patients with positive HCV antibody test results should only be included in this study if the PCR test for HCV RNA is negative. 9. Have a clear history of active tuberculosis; 10. Have an active autoimmune disorder that requires systemic therapy within the past 2 years (e.g., using disease-modifying drugs, corticosteroids, or immunosuppressive drugs) that allows for associated alternative therapy (e.g., thyroxine, insulin, or phytologenetic corticosteroid replacement therapy for renal or pituitary insufficiency); 11. Other serious, uncontrollable concomitant diseases that may affect protocol adherence or interfere with the interpretation of outcomes, including active opportunistic or advanced (severe) infections, uncontrollable diabetes mellitus, cardiovascular disease (Grade III or IV heart failure as defined by the New York Heart Association, heart block above degree II,myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months, etc.) or lung disease (interstitial pneumonia, history of obstructive pulmonary disease and symptomatic bronchospasm); 12. Those who received live vaccination within 4 weeks prior to the start of treatment; 13. Previously received allogeneic hematopoietic stem cell transplantation, graft or solid organ transplantation; 14. Persons with a history of psychotropic substance abuse who cannot be rehabilitated or who have a history of mental disorders; 15. Substantial pleural or ascites with clinical symptoms or requiring symptomatic treatment; 16. Have had other malignancies that have not healed in the past 5 years, but do not include malignancies that have been clearly cured, or that can be cured, such as basal skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, cervical carcinoma in situ or breast carcinoma in situ; Note: Patients with localized low-risk prostate cancer (defined as stage = T2a, Gleason score of =6, and PSA =10 ng/mL (as measured) at prostate cancer diagnosis who underwent radical surgery and no biochemical recurrence of prostate-specific antigen (PSA) may participate in this study); 17. Previous history of pelvic radiotherapy; 18. Merger of UTUC; 19. Depending on the investigator's opinion, there may be an increased risk associated with participating in the study, or other severe, acute or chronic medical illness or psychiatric disorder or laboratory abnormalities that may interfere with the interpretation of the findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year disease-free survival rate for intact bladder; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-week clinical complete response rate (cT0);Non-Muscular invasive bladder cancer recurrence rate;Metastasis-Free survival at two year;Bladder intact disease-free survival at two year; | — |
Countries
China
Contacts
Public ContactYaozong Xu
The Fifth People's Hospital of Shanghai,Fudan University
Outcome results
None listed