Muscle invasive bladder cancer cancer
Conditions
Interventions
Test Group:Zanidatamab + Tislelizumab + Cisplatin + Gemcitabine
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in this trial, able to provide written informed consent, and able to understand and agree to comply with the requirements of this study and the evaluation schedule. 2. The age at the date of signing informed consent was 18 to 85 years old. 3. Patients with residual lesions after TURBT, cT2-4aN0-1M0 bladder urothelial carcinoma based on the eighth edition of AJCC bladder cancer TNM staging, histological diagnosis and imaging evaluation ; patients with histologically mixed tumors are required to be dominated by urothelial carcinoma ( at least 50 % ). 4. Patients suitable for cisplatin treatment must be identified for researchers. Patients who are not suitable for cisplatin chemotherapy should meet at least one of the following criteria : ECOG physical status > 1 or Karnofsky physical status of 60 % to 70 % ; creatinine clearance rate was less than 60 mL / min. Hearing loss >= grade 2 in the fifth edition of the National Cancer Institute Common Terminology Criteria for Adverse Events ( NCI-CTCAE ) ; peripheral neuropathy >= grade 2 in NCI-CTCAE 5 th edition ; new York Heart Association class 3 or above heart failure 5. Tumor tissue samples of TURBT must be provided, and relevant pathological reports should be provided. 6. HER2 positive : immunohistochemistry ( IHC ) : 2 + or 3 +, interpretation criteria refer to ' Chinese urothelial carcinoma human epidermal growth factor receptor 2 detection clinical pathology expert consensus '. 7. Previous anti-HER2 targeted therapy ( not limited to HER2 antibody drugs, HER2 target ADC drugs and HER2 targeted TKI drugs ) and PD- ( L ) 1 drug therapy. 8. ECOG performance status 0 or 1 The patient 's organ function was good, measured by the following screening period laboratory test values ( obtained = 1.5x10^9 / L 2) Platelet >= 100 × 10^9 / L 3)Hemoglobin >= 90g / L (2) international normalized ratio or activated partial thromboplastin time = 60 mL / min ( Appendix 9 ) (4) Serum total bilirubin = 120 days after the last administration of Zenidatuzumab, Tirelizumab or chemotherapy ( whichever occurs later ).
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Uncontrolled infectious diseases requiring systemic treatment 3. Other malignant tumors diagnosed within 3.5 years. 4. Large surgery or major trauma occurred within 28 days before enrollment ( Implantation of vascular access devices and TURBT are not considered as major surgery ). 5. Previously received radiotherapy for bladder cancer 6. Active autoimmune diseases requiring systemic treatment, which the researchers assessed as having an impact on the study treatment 7. Any of the following cardiovascular criteria : (1) To study the presence of cardiogenic chest pain = grade 2 = 470 msec, male QTc >= 450 msec. (8) Note : If any patient 's first ECG result is QTc interval > 450 msec ( male ) or > 470 msec ( female ), follow-up ECG will be performed to verify the results. (9) Left ventricular ejection fraction ( LVEF ) <= 50 % was assessed by multi-gated acquisition ( MUGA ) scan or echocardiography ( ECHO ). The same method used in baseline assessment must be used for subsequent assessment. 8. A history of acute myocardial infarction or ischemic stroke within 8.6 months. 9. Human immunodeficiency virus ( HIV ) infection ( i.e. HIV 1-2 antibody positive ), active syphilis infection, active tuberculosis infection 10. Active hepatitis B virus ( HBV ) or hepatitis C virus ( HCV ) infection 11 Interstitial lung disease, non-infectious pneumonia or uncontrolled disease history, including pulmonary fibrosis, acute lung disease, etc. 12. Allergy to any of the drugs in this study 13. At the same time, participate in another clinical study, unless it is an observational ( non-interventional ) clinical study or in the follow-up period of an interventional study. 14. Other conditions judged by the researcher that did not meet the requirements of the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year BI-DFS;2-year BI-DFS; | — |
Countries
China
Contacts
Public ContactShaoxing Zhu
Fujian Medical University Union Hospital
Outcome results
None listed