Lung cancer
Conditions
Interventions
Experimental group:PD-1+chemotherapy
control group:chemotherapy
Sponsors
Gansu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 to 70 years; 2. Patients with ECoG score of 0-2; 3. Patients with an expected survival time of no less than 12 weeks; 4. Patients with non-small cell lung cancer (NSCLC) with negative driving gene confirmed by pathology (histology or cytology) (according to WHO classification 2015); 5. According to the eighth edition of TNM staging, the subjects were resectable stage ii-iiib (IIIB only t3n2) NSCLC; 6. Patients with measurable lesions (according to RECIST 1.1 standard, the long diameter of tumor lesions >=10 mm, and the short diameter of lymph node lesions >= 15 mm); 7. Patients without radiotherapy, chemotherapy, surgery and targeted therapy before enrollment; 8. Subjects must have sufficient lung function for the expected pneumonectomy; 9. Patients with normal main organ function meet the following criteria: (1) The blood routine examination standard should meet the following requirements: ANC >= 1.5 x 10^9/L; PLT >= 100 x 10^9/L; HB >= 90g/L; (2) Biochemical examination should meet the following standards: TBIL = 50 ml/min (Cockcroft Gault formula); (3) Coagulation function should be in accordance with INR <= 1.5 and APTT <= 1.5 ULN; 10. Women of childbearing age were required to have a serum pregnancy test within 3 days before the start of the study, and the results were negative, and they were willing to use a medically recognized high-efficiency contraceptive method (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study drug; for male subjects whose partners were women of childbearing age, surgical sterilization was required, Or agree to use effective contraceptive methods during the study and within 3 months after the last study administration; 11. The subjects volunteered to join the study and signed the informed consent. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Symptomatic patients with central nervous system metastasis; Two Patients with any history of active autoimmune disease or autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy)); patients with vitiligo or childhood asthma have been completely relieved and have no adult Patients who need any intervention can not be included; 3. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU / ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analysis method) or combined with hepatitis B and hepatitis C co infection; 4. Patients who had used immunosuppressive drugs within 14 days before the first use of the study drug did not include nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. prednisone or its equivalent not exceeding 10 mg / day); 5. Patients who received live attenuated vaccine within 4 weeks before the first administration or during the study period; 6. Patients with other malignant tumors in the past three years; 7. Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function; 8. Patients with uncontrolled hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg, despite the best drug treatment); 9. Patients with myocardial ischemia or myocardial infarction of grade II or above and arrhythmias with poor control (including QTc interval >= 450ms in males and >= 470ms in females). According to NYHA criteria, patients with grade III to IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% by echocardiography had myocardial infarction, NYHA grade II or above heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or acute ischemia or live as indicated by ECG Abnormal conduction system; 10. Patients with severe infection within 4 weeks before the first medication (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs), or fever of unknown origin > 38.5 degree C during screening / before first administration; 11. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12. Pregnant or lactating women; fertile patients who are unwilling or unable to take effective contraceptive measures; 13. Patients who are known to have allergic reaction, hypersensitivity or intolerance to calicizumab, albumin paclitaxel or their excipients; 14. Subjects who are participating in other clinical studies or taking the first medication for less than 4 weeks from the end of the previous clinical study (the last medication), or 5 half-life of the study drug; 15. Patients with known history of psychotropic substance abuse, alcoholism or drug use; 16. The researcher believes that there are any conditions that may damage the subjects or cause the subjects to be unable to meet or perform the research requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Surgical rate after downgrade;MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions;Surgical complications; | — |
Countries
China
Contacts
Public ContactBai Yue
Gansu Cancer Hospital
Outcome results
None listed