Lung Cancer
Conditions
Interventions
Prevention:Carrilizumab+Thalidomide
Treatment:Thalidomide was used as the basic regimen based on Carrilizumab.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 (including 18 and 75). 2.Stage IV non-small cell lung cancer confirmed by histopathology or cytology (according to the eighth edition of the International Alliance against Cancer / American Joint Committee on Cancer staging system). 3. At least 1 measurable lesion, according to RECIST 1.1standard. 4. Physical condition score (ECOG PS score): 0-1. 5. Estimated survival time = 6 months. 6.Negative for 6.EGFR or ALK mutation. 7. No active brain metastasis. 8. The function of the main organs is good, that is, within 14 days before entering the group, the relevant examination indexes meet the following requirements: hemoglobin = 90 g gamma L (no blood transfusion within 14 days); neutrophil count > 1.5 × 109 / L; platelet count = 100 × 109 / L; total bilirubin = 1.5×ULN (upper limit of normal value); blood glutamic pyruvic transaminase (ALT) or blood glutamic oxaloacetic transaminase (AST) = 2.5×ULN; if there is liver metastasis, ALT or AST = 5 × ULN. Endogenous creatinine clearance = 60 mL/min (Cockcroft-Gault formula); left ventricular ejection fraction (LVEF) = 50% evaluated by Doppler echocardiography. 9. Women of childbearing age must have a serum pregnancy study within 7 days before the first medication, and the result is negative. Women of childbearing age and men whose partners are women of childbearing age must agree to use efficient methods of contraception during the study and within 180 days after the last administration of the study drug. 10. Understand the research steps and contents, and voluntarily sign a written informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients with known EGFR mutation or ALK positive. 2. Patients with active central nervous system (CNS) metastasis. If the patient's CNS metastasis can be adequately treated, such as clinical stability (MRI test) has been maintained for at least 4 weeks, and the patient's clinical symptoms such as nervous system can return to the baseline level at least 2 weeks before the first medication (except for residual signs or symptoms associated with CNS treatment), you can participate in the study. In addition, if patients were treated with corticosteroids for related clinical symptoms, they could not be enrolled in the study if they received a stable or gradually reduced dose of prednisone (or equivalent) of = 10 mg/ days for at least 2 weeks. 3. Patients with active, known or suspected autoimmune diseases. Patients with type I diabetes who received stable dose insulin therapy, patients with hypothyroidism who only needed hormone replacement therapy, and skin diseases (such as eczema, vitiligo or cattle) that did not require systematic treatment and had no acute deterioration in the year prior to the screening period. 4. Suffer from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection. 5. Suffer from the following poorly controlled infectious diseases: active hepatitis B (HBsAg positive and HBV DNA = 500IU/ml or 1000copies/ml) or hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection by analytical method); active tuberculosis or currently receiving anti-tuberculosis treatment. 6. Past or present objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (such as bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia or severe impairment of lung function in CT examination. 7. Cardiac function and disease are in accordance with one of the following conditions, the researchers believe that it has clinical significance, obvious abnormality and is not suitable for the arrhythmias in this study, including but not limited to complete left bundle branch conduction abnormality, II degree atrioventricular block; 12-lead electrocardiogram (ECG) measurement, QTc interval = 450ms in males and = 470ms in females. New York Heart Association (NYHA) grade = 3 cardiac insufficiency or color Doppler echocardiography: left ventricular ejection fraction (LVEF) 2), such as infection complications, bacteremia, severe pneumonia, etc.; symptoms and signs of infection within 2 weeks before the first use of drugs require oral or intravenous use of antibiotics (excluding prophylactic use of antibiotics) patients who need systemic use of antibiotics due to infection. 9. Diagnosed with immunodeficiency or the study is receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy not directly related to tumor treatment within 7 days before the study; physiological dose of glucocorticoid (prednisone or equivalent for = 10 mg/ days) is allowed. 10. The patients were complicated with other malignant tumors less than 5 years before enrollment, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation and ductal carcinoma in situ after radical resection. 11. Major surgery (excludin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of RCCEP;RCCEP efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;ORR; | — |
Countries
China
Contacts
Public ContactGu Kangsheng
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed