Urothelial Bladder Cancer
Conditions
Interventions
Case series:Neoadjuvant Toripalimab Before Cystectomy
Sponsors
Department of Urology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. ECOG PS 0 to 2; 3. Patients need to undergo TURBT and imaging diagnosis before the trial.Histopathologically confirmed transitional cell carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.And patients should fit and planned for radical cystectomy + lymphadenectomy + urinary diversion; 4. Clinical stage T2-T4a N0 M0 disease by CT (or MRI) + PET/CT,if Clinical stage T2-T4a N1-3 M0,it needs to be judged by the researcher(surgical opinion, cystoscopy); 5. Residual disease after TURB (surgical opinion, cystoscopy); 6. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens (blocks preferred); 7. Expected survival >=3 months; 8. Adequate hematologic and end-organ function tests: (1) Standard blood test: HB>=90 g/L; ANC>=1.5x10^9/L; PLT>=100x10^9/L; (2) Non-functional organic diseases: T-BIL20ml/min (Cockcroft-Gault); aPTT<=1.5 ULN; 9. Have not received systemic corticosteroids therapy within 4 weeks; 10. potential men or women for pregnancy must use highly effective contraception during the trial; 11. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Previously anti-PD-1,anti-PD-L1. anti-PD-L2 therrapy 2.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 3.Have received other anti-tumor treatments (including corticosteroids, immunotherapy) or participated in other clinical trials within 4 weeks before , or have not recovered from the previous toxicity (except for 2 degree hair loss and 1 degree neurotoxicity) 4.Pregnant female patients. 5.Positive test for HIV. 6.Patients with active hepatitis infection 7.Patients with active tuberculosis. 8.Have active autoimmune diseases that require systemic treatment in the past 2 years (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs) and allow related alternative therapies (such as thyroxine, insulin, or physiology of renal or pituitary insufficiency Corticosteroid replacement therapy); 9.Other severe, uncontrollable diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic or advanced (severe) infections, uncontrolled diabetes, cardiovascular disease (defined by the New York Heart Association classification Grade III or IV heart failure, cardiac block above Grade ?, 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 pulmonary disease and symptomatic bronchospasm); 10.Received alive vaccination within 4 weeks before the start of treatment; 11.Have previously received an allogeneic hematopoietic stem cell transplant or a solid organ transplant; 12.With a history of psychotropic substance abuse who are unable to quit or have a history of mental disorders 13.Large amounts of pleural or ascites with clinical symptoms or requiring symptomatic treatment; 14.Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score = 3 + 4 and PSA < 10 ng/mL undergoing active surveillance and treatment naive). 15.Combined with upper urinary urothelial carcinoma (kidney, ureteral urothelial carcinoma) 16.Other severe, acute or chronic medical or mental illness or laboratory abnormalities that may interfere with the interpretation of the results of the study judged by researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ypCR;Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;CSS;OS;post-operative complications; | — |
Countries
China
Contacts
Public ContactHaige Chen
Department of Urology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed