Lung cancer
Conditions
Interventions
single arm:carilizumab combined with apatinib
Sponsors
Nanjing Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged >= 18 years old; 2. Patients with NSCLC confirmed by histopathology or cytology; 3. Patients with EGFR / ALK gene wild-type, who have experienced disease progression after previous treatment with platinum containing first-line standard chemotherapy; 4. Patients with EGFR gene mutation or ALK gene rearrangement, who have received standard treatment to obtain disease progress and have TP53 gene mutation detected; 5. According to the RECIST 1.1 standard, patients with at least one target lesion with measurable diameter line (CT scan length diameter of tumor lesions >= 10 mm, CT scan short diameter of lymph node lesions >= 15 mm, and scan layer thickness no more than 5 mm); 6. The patients whose physical fitness score (PS) of who / ECoG was 0 or 1 were enrolled; 7. All screening period laboratory tests will be performed in accordance with the protocol requirements and within 14 days prior to enrollment. The value of laboratory test must meet the following criteria: routine blood test (no blood transfusion, no G-CSF, no medication correction within 14 days before screening): 1) HB >= 90 g / L; 2) ANC >= 1.5 x 10^9 / L; 3) PLT >= 80 x 10^9 / L; biochemical test (no ALB within 14 days): 1) TBIL < 1.5 x ULN; 2) bilirubin <= 1.5 x ULN, ALT and AST <= 2.5 x ULN, If there is liver metastasis, ALT and AST are less than 5 x ULN; 3) serum Cr is less than 1.25 × ULN or endogenous creatinine clearance is more than 45 ml / min (Cockcroft Gault formula); 8. Those patients who are willing to join the study voluntarily and sign informed consent, have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; the subject has vitiligo or asthma in childhood has been completely relieved, no need of any dry after adulthood) Asthma patients who need medical intervention with bronchodilator can not be included; 2. Patients with active infection, including tuberculosis, hepatitis B, hepatitis C (HCV) or human immunodeficiency virus (HIV) 1 / 2 antibody positive); 3. The results of histology were mixed SCLC and NSCLC; 4. Patients who are using immunosuppressive agents, or systemic or absorbable local hormones to achieve the purpose of immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones), and continue to use them in the first two weeks before entering the group; 5. Patients with severe allergic reactions to other monoclonal antibodies; 6. Patients whose imaging shows that the tumor has invaded the important blood vessels or who are highly likely to invade the important blood vessels during the treatment period and cause fatal massive hemorrhage according to the judgment of researchers; 7. Patients with hypertension who can not get good control after antihypertensive drug treatment (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 8. Patients with clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure above NYHA Level 2; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; 9. Patients with abnormal coagulation and bleeding tendency (14 days before randomization: INR is within the normal range without anticoagulant); patients treated with anticoagulant or vitamin K antagonists such as warfarin, heparin or their analogues; INR in prothrombin time Under the premise of 1.5, it is allowed to use low-dose warfarin (1 mg orally once a day) or low-dose aspirin (no more than 100 mg daily) for prevention purpose; 10. In the six months before screening, the patients who have had the event of arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by venous catheterization due to pre chemotherapy, which is judged to be cured by the researchers) and pulmonary embolism, etc; 11. Patients with multiple factors (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) affecting oral drugs; 12. There are patients / social conditions that restrict the compliance with research requirements, significantly increase the risk of AE or affect the ability to provide written informed consent; 13. Pregnant or lactating women; 14. The researchers determined that other circumstances were not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;ORR; | — |
Countries
China
Contacts
Public ContactShencun Fang
Nanjing Chest Hospital
Outcome results
None listed