Urothelial carcinoma
Conditions
Interventions
experimental group:Nivolumab combined with Sitagliptin as adjuvant therapy
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Voluntarily participate in this trial, be able to provide written informed consent, and understand and agree to comply with the requirements of this study as well as the evaluation schedule. Radical resection of the tumor must have been performed within the past 90 days; Patients with urothelial carcinoma with postoperative pathological stage ypT2-T4aNxM0 after neoadjuvant therapy; or patients with urothelial carcinoma who have not received neoadjuvant therapy and have a postoperative pathological stage of pT3-T4aNxM0; ECOG status is 0 or 1; Gender is not limited, age > = 18 years and = 12 weeks; Adequate organ function: (1) Absolute neutrophil count (ANC) >=1.5×10^9/L (2) Platelets>=100×10^9/L (3) Total serum creatinine =50% (6) Hemoglobin >=90 g/L
Exclusion criteria
Exclusion criteria: Known history of severe allergic reaction to humanized monoclonal antibody and PD-1 inhibitor, sitagliptin; Received any chemotherapy, radiotherapy, cancer biologics, investigational therapy, etc., outside of the treatment regimen within 30 days of the first dose of study treatment; Treatment with a DPP4 inhibitor within 60 days prior to the first dose of study treatment; Diabetic patients who are using any hypoglycemic drugs (including long/short-acting insulin, DPP4 inhibitors, GLP-1 receptor agonists, etc.); Currently known HIV or severe chronic or active infection (including active tuberculosis in the active phase), untreated chronic hepatitis B patient/carrier; Participants with known active autoimmune disease or a history of autoimmune disease that has the potential for relapse; Subjects should be excluded if they have conditions requiring systemic treatment with corticosteroids (> 10 mg prednisone equivalent per day) or other immunosuppressive drugs within 14 days of taking the study drug; Pregnancy or lactation; Currently active clinically significant cardiovascular disease, such as uncontrolled cardiac arrhythmia, congestive heart failure, or >= category 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or a history of unstable angina pectoris with myocardial infarction; Previous clear history of neurological or psychiatric disorders, including epilepsy or dementia; Other serious other systemic diseases that may limit the patient's participation in this study (such as cardiovascular and cerebrovascular diseases, severe gastrointestinal diseases, and renal diseases, etc.); Patients who, in the opinion of the investigator, are not suitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limiting toxicity;2 year disease-free survival rate;Disease-specific survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactWang He
Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Outcome results
None listed