Bladder cancer
Conditions
Interventions
Treatment group:RC48+tislelizumab
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent form, good compliance, and cooperate with follow-up. 2. Age= 18 years old, gender is unlimited. 3.ECOG=1 4.Urothelial carcinoma of the bladder diagnosed with cT2-4a by clinical cystoscopy and pathological examination, and pelvic MRI was completed before cystoscopy to determine the extent of the lesion. 5. The pathology is urothelial carcinoma, and the patient's HER2 expression IHC 2+ and above is strongly positive (central laboratory verification). 6. Life expectancy> 3 months. 7. Relevant laboratory tests should be performed within 14 days of entering treatment, and the laboratory tests done should meet the following standards: routine blood examination (no blood transfusion, no use of G-CSF, no drug correction within 14 days before the examination): HB=90g/L; (2)ANC=1.5×109/L; (3)PLT=80×109/L; Biochemical tests (no albumin transfusion 14 days before the examination) :(1) TBIL=1.5×ULN; (2) ALT and AST=2.5×ULN; (3) Serum Cr= 1.25× ULN or endogenous creatinine clearance = 30mL/min.
Exclusion criteria
Exclusion criteria: 1. The patient has any active, known or suspected autoimmune disease. Enrollment is allowed in patients who are stable and do not require systemic immunosuppressant therapy. 2. Patients who need systemic therapy with corticosteroids or other immunosuppressants within 14 days before the drug is given. 3. Patients who meet all inclusion criteria for this study have received HER2-targeted therapy, immunotherapy, or chemotherapy within 6 months prior to this study. 4. Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint co-pathway). 5. Those who develop any of the following symptoms within 6 months before the administration of the drug: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or pulmonary embolism. 6. Patients with high suspicion of interstitial pneumonia; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity. 7. Other active malignancies requiring concurrent treatment, including upper tract urothelial carcinoma. 8. Receive live attenuated vaccine within 4 weeks prior to enrollment or planned for the duration of the study. 9. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 10. Patients with active pulmonary tuberculosis should be excluded. Patients with suspected active pulmonary tuberculosis require chest x-ray, sputum, and exclusion by clinical signs and symptoms. Patients with a history of active tuberculosis infection within the previous 1 year should be excluded, even if they have been treated; Patients with a history of active TB infection more than 1 year ago should also be excluded unless the course and type of all previous antituberculous therapies are demonstrated. 11. Patients who have experienced exclusion due to PD-L1 negative status in any anti-PD-1 or anti-PD-L1 antibody clinical trial. 12. Known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome. 13. Untreated active pneumonia (hepatitis B: HBsAg positive and HBC DNA = 500 IU/mL; Hepatitis C: HCV RNA positive and abnormal liver function); Co-infection with hepatitis B and C. 14. Patients with grade =2 peripheral neuropathy. 15. Those who are known to be allergic to PD-1 monoclonal antibody/vedicitumab and its components. 16. Severe allergic reactions to other monoclonal antibodies. 17. Have experienced allergies or intolerances to infusions. 18. The investigator determines that the patient has other factors that may cause the study to be terminated halfway, such as other diseases or serious laboratory abnormalities or other factors that will affect the safety of the patient, or the family or society of the test data and sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical complete response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The 2-year metastasis-free survival rate;Pathological complete response rate; | — |
Countries
China
Contacts
Public ContactJunxing Chen
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed