non-small cell lung cancer (NSCLC)
Conditions
Interventions
Experimental group:Camrelizunb
Sponsors
Jiangyin People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 years (including 18 and 75); 2. Understand the research steps and content, and voluntarily sign a written informed consent; 3. Advanced non-small cell lung cancer diagnosed by histopathology and/or cytology; 4. There is at least one measurable lesion, according to RECIST 1.1 criteria; 5. Have not received systemic chemotherapy in the past; 6. Physical condition score (ECOG PS score): 0-1 points; 7. Expected survival period >= 3 months; 8. The function of major organs is good, that is, the relevant inspection indicators meet the following requirements within 14 days before enrollment: hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count> 1.5x10^9/L; platelet count >= 100x10^9/L; total bilirubin = 60 mL/min (Cockcroft-Gault formula); cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; 9. Thyroid function indicators: Thyroid-stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range or mild and no clinically significant abnormalities; 10. Weight over 40 kg (including 40 kg), or BMI > 18.5.
Exclusion criteria
Exclusion criteria: 1. Participated in clinical trials of other drugs within four weeks; 2. There are multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 3. There is a history of bleeding, and any bleeding event with a severe grade of CTCAE5.0 grade 3 or above occurs within 4 weeks before screening; 4. Patients with known central nervous system metastasis or a history of central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; 5. Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmia (including QTcF: >=450 ms for men, >=470 ms for women) requires long-term use of antiarrhythmic drugs and New York Heart Association classification >= grade II cardiac insufficiency; 6. Imaging shows that the tumor has invaded around important blood vessels or the investigator judges that the patient's tumor has a high possibility of invading important blood vessels during treatment and causing fatal hemorrhage; 7. Abnormal coagulation function and bleeding tendency (must be satisfied 14 days before randomization: the INR is within the normal range without the use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; on the premise of prothrombin time international normalized ratio (INR) <= 1.5, low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (no more than 100 mg per day) is allowed for prophylaxis; 8. Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 9. Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients who need corticosteroids; 10. History of severe chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, history of chronic diarrheal diseases such as irritable bowel syndrome; have a history of sarcoidosis or tuberculosis; 11. Patients with hypersensitivity to human or murine monoclonal antibodies; 12. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 13. Pleural effusion or ascites with clinical symptoms requiring clinical intervention; 14. Patients who do not follow doctor's orders, do not take medicines as prescribed, or have incomplete information, which may affect the judgment of efficacy or safety; 15. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactShen Dong
Jiangyin People's Hospital
Outcome results
None listed