Lung Cancer
Conditions
Interventions
single arm:camrelizumab + bevacizumab+pemetrexed
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years and = 1.5 x 10^9 / L, platelet count >= 100 x 10^9 / L, exclusion criteria, hemoglobin >= 90 g / L; 8. Adequate liver function: aspartate aminotransferase (AST) = 50ml / min (Cockcroft Gault formula); 10. Sufficient coagulation function: international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times the upper limit of normal; if the patient is receiving anticoagulant therapy, INR / Pt is within the range of anticoagulant drugs; 11. Patients who need to use effective contraception and continue to use it for at least 180 days after stopping the trial treatment. It was confirmed that the urine pregnancy test or serum pregnancy test was negative within 3 days before the first study drug administration. 12. Subjects who understood and voluntarily signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with squamous cell or mixed type NSCLC with squamous cell morphology. 2. Patients with mixed lung cancer who have small cell carcinoma, neuroendocrine carcinoma and sarcoma can not be included in the group; 3. Patients with EGFR mutation, ALK fusion mutation, c-Met mutation, ros-1 mutation, etc. 4. Patients who have suffered from any arterial thrombosis, embolism or ischemic or hemorrhagic diseases in the past 6 months and have not improved or become unstable after corresponding treatment, such as unstable myocardial infarction, unstable angina pectoris, cerebrovascular accident, etc; 5. For patients with hemoptysis in recent 3 months, the amount of bleeding was defined as bright red blood greater than or equal to 2.5ml. 6. Other malignant tumors were diagnosed in the past five years, excluding basal cell carcinoma of skin, squamous cell carcinoma of skin and / or carcinoma in situ after radical resection; 7. Patients or contraindications who have been proved to be allergic to karelizumab, bevacizumab, pemetrexed or their excipients; 8. Patients with NSCLC who do not receive chemotherapy or are expected to be intolerable to chemotherapy; 9. There are those patients who interfere with the clinical trial, hinder the full participation of the subjects, or the researchers think it is not in the best interests of the subjects; 10. Patients with grade 2 or above hypertension before treatment and no improvement or instability after antihypertensive drug treatment; patients with hypertensive crisis or hypertensive encephalopathy; 11. Patients with nephrotic syndrome or proteinuria >= 2 + or above before treatment, and patients without improvement or instability after treatment; 12. Patients who need surgical treatment in the past 60 days; 13. Patients with history of gastrointestinal perforation in recent 6 months; 14. Patients with previous history of severe brain diseases, especially those with grade III / IV white matter lesions; 15. Congenital or acquired immune deficiency (such as HIV) Patients with any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can be controlled by hormone replacement therapy only] were included); patients with active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) Patients with skin diseases without systemic treatment, such as vitiligo, psoriasis and alopecia, controlled type I diabetes treated with insulin or asthma in childhood, and without any intervention in adulthood, can be included; patients with asthma requiring medical intervention with bronchodilators can not be included; 16. Patients with previous and current history of pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), interstitial pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or evidence of active pneumonia or severe impairment of lung function on chest computed tomography (CT) during screening may interfere with the detection and management of suspected drug-related pulmonary toxicity The patients had radiation pneumonitis, active tuberculosis, and other diseases; 17. Pat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;TTR; | — |
Countries
China
Contacts
Public ContactJie Liu
Shandong Cancer Hospital
Outcome results
None listed