Non small cell lung cancer
Conditions
Interventions
Experimental group:Endostar and carrilizumab combined with chemotherapy were given
Sponsors
Nanping First Hospital Affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Stage IV non-small cell lung cancer (NSCLC) confirmed by histology or pathology; 2.No EGFR, ALK, Ros-1 gene mutation (if it is negative by peripheral blood free DNA test, it is necessary to increase the detection of tissue samples; Patients with squamous cell carcinoma of the lung may not undergo gene testing; 3.At least one measurable lesion (RECIST version 1.1); 4.The expected survival time is more than 3 months; 5.ECOG PS score was 0-1; 6.The laboratory test values of patients before medication should meet the following standards: (1)Blood routine: WBC >=3.0 x10^9/L,ANC>=1.5 x10^9/L,PLT>=80x10^9/L,HGB>=9.0 g/dL; (2)Liver function: AST = 50 ml / min; (4)Coagulation function: INR <= 1.5 x ULN, APTT<=1.5 x ULN; 7.Women of childbearing age should have pregnancy test (serum or urine) within 14 days before enrollment, and the result is negative; Male subjects and women of childbearing age were required to use contraception within 24 weeks from the beginning of the first dose of the study drug to the end of the study drug.
Exclusion criteria
Exclusion criteria: 1.Histologically or cytologically, the tumor was proved to be mixed adenosquamous carcinoma or small cell lung cancer; 2.Known or suspected active autoimmune diseases; 3.Have a history of immunodeficiency or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation; 4.Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid therapy, active pneumonia with clinical symptoms or severe pulmonary dysfunction; 5.The subjects had cardiovascular clinical symptoms or diseases that could not be well controlled, including but not limited to: (1)Heart failure of NYHA grade II or above; (2)Unstable angina pectoris; (3)Myocardial infarction within one year; (4)Clinically significant supraventricular or ventricular arrhythmias were still poorly controlled without clinical intervention or after clinical intervention. 6.Active central nervous system metastasis, including symptomatic brain metastasis, meningeal metastasis, spinal cord compression, etc. However, patients with brain metastasis and spinal cord metastasis who have completed local treatment for more than 4 weeks and no longer need corticosteroid treatment can be enrolled; For asymptomatic patients with brain metastases less than or equal to 3 and less than 10 mm, whether they are included in the study was judged by the researcher; 7.Patients with bleeding tendency, high risk of bleeding or coagulation dysfunction, including thrombotic disease within 6 months before screening and / or hemoptysis within 3 months before screening (cough bleeding volume >= 2.5ml); Patients with tumor cavity or signs of tumor invasion into large blood vessels. 8.The subjects had active hepatitis B (HBV DNA >= 2000 IU / ml or 104 copies / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit); 9.Known or suspected allergy to the test drug and its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective remission rate;disease control rate;security; | — |
Countries
China
Contacts
Public ContactChen Shengchi
Nanping First Hospital Affiliated to Fujian Medical University
Outcome results
None listed