Bladder Urothelial Cancer
Conditions
Interventions
Intervention group:Tislelizumab+Gemcitabine+Cisplatin
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Each patient eligible for this study must meet the following criteria: 1. Patients who voluntarily participate in the trial, can provide written informed consent, and understand and agree to comply with the requirements of this study and evaluation schedule; 2. Patients aged 18 to 75 years on the date of signing informed consent; 3. Patients with ct2-t4an0m0 bladder urothelial carcinoma based on AJCC eighth edition TNM staging, histological diagnosis and imaging evaluation; patients with mixed histology were required to be dominated by urothelial carcinoma (at least 50%); 4. Patients who are suitable for cisplatin treatment must be determined for the investigator. Patients who are not suitable for cisplatin chemotherapy should meet at least one of the following criteria: ECoG physical status > 1 or Karnofsky fitness status of 60% to 70%; creatinine clearance rate less than 60 ml / min; hearing loss >=2 grade in (NCI-CTCAE) 5th Edition; peripheral neuropathy >=2 grade in NCI-CTCAE 5th Edition; Patients with NYHA grade III or above heart failure; (Appendix 3) 5. According to the evaluation of researchers, patients who need radical cystectomy after neoadjuvant therapy and meet the indications of radical cystectomy are willing to accept the operation; 6. Tumor tissue samples of TURBT must be provided, and relevant pathological reports should be provided. Fresh surgical tissues or pathological white films can be selected (refer to the sample management manual of central laboratory); 7. ECoG physical status 0 or 1 (Appendix 2); 8. The organ function of patients was good, which was measured by the following laboratory test values (obtained =1.5x10^9/l; 2) Platelet >= 100x10^9/L; 3) Hemoglobin >= 90g/L; (2) International normalized ratio or activated partial thromboplastin time =60 ml/min; (4) Serum total bilirubin 1.5 ULN (if Gilbert syndrome or indirect bilirubin concentration shows extrahepatic increase, it should be <=3 ULN); (5) Ast, ALT and ALP <=2.5 ULN; (6) Lung function suggests that abdominal surgery can be tolerated; 9. Non pregnant or fertile women must be willing to take high-efficiency contraceptive measures during the study period and more than 120 days after the last administration of tiririzumab or chemotherapy drug (whichever occurs later), and have negative urine or serum pregnancy test results within <=7 days before enrollment; 10. Non sterile men must be willing to take high-efficiency contraceptive measures during the study and not less than 120 days after the last administration of tirelizumab or chemotherapy (whichever occurs later).
Exclusion criteria
Exclusion criteria: Patients who met any of the following criteria did not meet the inclusion criteria: 1. Patients who have previously received therapy targeting PD-1, PD-L1, PD-L2, CTLA4 or other antibody or drug therapy specifically targeting T-cell costimulation or checkpoint channel; 2. Patients receiving other approved systemic anti-cancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin-2 and tumor necrosis factor) within 28 days before enrollment; 3. Patients who have received radiotherapy for bladder cancer in the past; 4. Patients who have previously received drug therapy for cancer, except for the following: (1) For patients who had previously received systemic chemotherapy, there was no treatment interval of at least 12 months from the last treatment to the beginning of neoadjuvant therapy; (2) Local intravesical chemotherapy or immunotherapy should be completed at least one week before the start of neoadjuvant therapy; 5. Patients who had undergone major surgery or major trauma within 28 days before enrollment (vascular access device implantation and TURBT were not considered as major surgery); 6. Patients with severe chronic or active infection who need systemic anti bacterial, antifungal or antiviral treatment within 14 days before enrollment (HBV infection should be carried out according to exclusion criteria 12); 7. Patients vaccinated with live vaccine within 28 days before enrollment (seasonal influenza vaccine is usually inactivated vaccine, so it is allowed to be used. Intranasal vaccines are live vaccines, so they are not allowed to be used); 8. Patients who have received any Chinese herbal medicine or Chinese patent medicine for cancer control within 14 days before enrollment;(Appendix 4) 9. Patients with active autoimmune diseases requiring systemic treatment were assessed by the researchers as having an impact on the study treatment (Appendix 5); 10. For patients who need long-term heavy use of hormones or other immunosuppressants, the researchers evaluate that those patients have an impact on the study treatment; 11. Patients with abnormal potassium, sodium, calcium or history of hypoalbuminemia, interstitial lung disease, noninfectious pneumonia or other uncontrolled systemic diseases, including diabetes mellitus, hypertension, cardiovascular disease (e.g. before enrollment, 6 There were active heart diseases within months, including severe / unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmias requiring drug treatment, etc.; 12. Subjects with HBV DNA >=500 IU / ml (2500 copies / ml) without treatment or carriers of hepatitis B virus (HBV) were not allowed into the study. Note: inactive HBsAg carriers or patients with stable active HBV infection (HBV DNA < 500 IU / ml [2500 copies / ml]) after continuous antiviral treatment can be enrolled. HBV DNA testing is only performed in patients with positive anti HBcAg antibodies; 13. Patients with active hepatitis C should not be enrolled. Patients with negative HCV antibody test in screening period or HCV RNA negative after HCV antibody test can be enrolled. Only patients with positive HCV antibody test need HCV RNA test; 14. Patients with a history of immunodeficiency (including HIV positive, other acquired and congenital immunodeficiency diseases) or a history of allogeneic stem cell transplantation or organ transplantation; 15. Patients known to be allergic to other monoclonal antib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic downstaging rate;Survival;Safety; | — |
Countries
China
Contacts
Public ContactJian Huang
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed