Bevacizumab Combined With Gefitinib in the Treatment of Advanced NSCLC

Exclusion Criteria

• •1. Histology or cytology confirmed mixed adenocarcinoma with squamous cells as the main component (the proportion of squamous cells ≥ 10%).
• •2. There was a history of malignancy (except NSCLC) in the first 5 years before randomization, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as cervical carcinoma in situ, non melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer, which were treated appropriately.
• •3. Previous hypertensive crisis, hypertensive encephalopathy, or uncontrolled hypertension (blood pressure: systolic pressure \> 150 mmHg and / or diastolic pressure \> 100 mmHg).
• •4. The tumor invades the main blood vessels. Researchers or local radiologists must rule out evidence that the tumor is completely adjacent to, surrounding, or extending into the lumen of a major artery, such as the pulmonary artery or superior vena cava.
• •5. Any other disease, neurological or metabolic dysfunction; medical examination or laboratory finding that a disease or condition is suspected, which prohibits the use of the test drug or exposes the patient to a high risk of treatment-related complications.
• •6. It is highly suspected that there are patients with idiopathic pulmonary fibrosis, organic pneumonia, drug-related pneumonia, idiopathic pneumonia, active pneumonia or active tuberculosis.
• •7. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently) allows patients to retain catheters.
• •8. History of hereditary bleeding constitution or coagulation disorder or other evidence of increased bleeding risk.
• •9. There are non healing wounds, active ulcers or fractures.
• •10. Patients with tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, and intraperitoneal abscess in the first 6 months were randomly assigned.
• •11. Cardiovascular diseases with clinical significance (such as active), including but not limited to TIA (within 6 months before screening), myocardial infarction (within 6 months before screening), unstable angina, congestive heart failure with New York Heart Association classification ≥ level II (see Appendix 3), and serious arrhythmias beyond the control of drugs.
• •12. Within 3 months before randomization, there was a history of hemoptysis ≥ 2 levels, that is, the blood volume of each bleeding event was \> 2.5ml.
• •13. Evidence of central nervous system metastasis, except for patients without any symptoms or patients with symptoms but stable condition, at least 28 days after treatment of central nervous system metastasis.
• •14. Major surgery (including open biopsy) or severe trauma was performed within 28 days prior to randomization, or was expected to be performed during study treatment.
• •Severe infections occurring within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
• •16 aspirin (325 mg / day) or other non steroidal anti-inflammatory drugs known to inhibit platelet function are currently or recently used (within 10 days before bevacizumab was first used).
• •17 full dose oral or parenteral anticoagulants or thrombolytic agents are currently or recently used (within 10 days prior to the first use of bevacizumab). Preventive use of anticoagulants is permitted.
• •18\. Core biopsies or other minor operations were performed within 7 days prior to randomization, but vascular access devices were not included. Vascular access devices should be placed at least 2 days before the start of study treatment.
• •19\. Those who are known to be allergic to bevacizumab, gefitinib and their excipients, or to Chinese hamster ovarian cell products or other recombinant human or humanized antibodies.
• •20\. Those who were confirmed to be HCV positive, HIV positive, syphilis positive, or HBsAg positive during the screening period, and whose HBV DNA titer in the peripheral blood was ≥ 1000 copies / L.
• •21\. Pregnancy or lactation, or pregnancy planning during the study. 22. Those who participated in any other clinical trial and took the trial drug treatment within 30 days before randomization.
• •23\. The investigator determined that the risk of the subject was greater than any other benefit.