non-small cell lung cancer (NSCLC)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients are required to sign an informed consent form (ICF) before starting the relevant operation; 2. Aged 18~75 years; 3. Gender is not limited; 4. Lung adenocarcinoma confirmed by histopathology or cytology, and patients with operable stage II-III tumors (8th TNM); 5. Eastern Cooperative Oncology Group (ECOG) physical status score =1.5x10^9/L, platelet count >=100x10^9/L, and hemoglobin >=90g/L; 11. Good liver function, defined as total bilirubin level = 60 mL/min (Cockcroft-Gault formula), urine routine examination urine protein less than 2+, or 24-hour urine protein quantification <1 g; 13. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times the upper limit of normal (ULN); 14. For female patients of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Cycle 1, Day 1). A blood pregnancy test is required if a urine pregnancy test result cannot be confirmed negative; 15. Use of highly effective contraception (ie, a method with a failure rate of less than 1% per year) in both male and female patients if there is a risk of conception, for at least 180 days after discontinuation of trial treatment.
Exclusion criteria
Exclusion criteria: 1. Proven allergy to the test drug and/or its excipients; 2. Have any active autoimmune disease or history of autoimmune disease; Patients with complete remission of childhood asthma without any intervention or vitiligo in adulthood could be included, but not those requiring medical intervention with bronchodilators; 3. Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA>=500 IU/mL), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C; Or have a history of organ transplantation; 4. Clinical symptoms or diseases of heart that are not well controlled, such as: (1) NYHA2 or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; 5. Lactating patients; 6. Patients judged by the researchers to be unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response;complete pathological response rate; | — |
Countries
China
Contacts
First Affiliated Hospital of Anhui Medical University