Non-small cell lung cancer (NSCLC)
Conditions
Interventions
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 75 years . 2. Stage II-IIIA NSCLC, confirmed by histology/cytology. 3. Pulmonary function: lobectomy FEV1>1.5; pneumonectomy FEV1>2.0. 4. Receive radical surgical resection. 5. Has adequate organ and bone marrow function: (1) Blood routine: absolute neutrophil count (ANC) >= 1.0x10^9/L; platelet count (PLT) >=75x10^9/L; hemoglobin (HGB) >=8.5 g/dL. (2) Liver function: serum total bilirubin (TBIL) =28 g/L; alkaline phosphatase (ALP)= 50mL/min (Cockcroft-Gault formula); urine routine results show urine protein =2+ at baseline, 24-hour urine collection should be performed and 24-hour urine protein quantification should be less than 1 g. (4) Coagulation function: International normalized ratio (INR) <= 2, and activated partial thromboplastin time (APTT) <= 1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Non-small cell lung cancer with distant metastasis (M1 stage). 2. EGFR, ALK, ROS1 gene sensitive mutations. 3. Any life-threatening bleeding events in the past 3 months, including the need for blood transfusion therapy, surgery or local therapy, and continuous drug therapy. 4. Arterial and venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other history of severe thromboembolism. Thrombosis due to implanted venous port or catheter-derived thrombosis, or superficial vein thrombosis, except for those with stable thrombus after conventional anticoagulation therapy. Prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed. 5. Uncontrolled hypertension, systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy. 6. Symptomatic congestive heart failure (New York Heart Association class II-IV). Symptomatic or poorly controlled cardiac arrhythmias. QT interval prolongation, QTc>450ms (male), QTc>470ms (female). 7. Severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic therapy. 8. History of gastrointestinal perforation and/or fistula within the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. 9. History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia or active pneumonia. 10. Active pulmonary tuberculosis (TB), who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before the first drug. 11. Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive). Serious infections that are active or poorly controlled clinically. Severe infection within 4 weeks prior to first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 12. Active autoimmune disease requiring systemic treatment or history of the disease within the past 2 years (Vitiligo, psoriasis, alopecia, or Grave's disease not requiring systemic therapy within the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type I diabetes requiring only insulin replacement therapy can be included). Known history of primary immunodeficiency. Only patients with positive autoimmune antibodies need to confirm whether there is an autoimmune disease according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Countries
China
Contacts
Public ContactZhang Zhenrong
China-Japan Friendship Hospital
Outcome results
None listed