Non-small cell lung cancer
Conditions
Interventions
The experimental group: Anlotinib
The control group:AP, AC, PC
Sponsors
Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this study and sign informed consent, with good compliance and follow-up; 2. Male or female patients aged between 18 and 75 years; 3. Patients with stage II-IIIA non-small cell lung cancer initially treated by complete resection and histologically confirmed. Staging should be based on the American Joint Committee on Cancer (AJCC) NSCLC Staging System Version 8; 4. ECOG score: 0-1 5. Estimated survival >= 6 months; 6. The main organs are functioning normally, i.e. they meet the following criteria: 1) Blood routine examination standards shall meet: a) Absolute value of ANC of neutrophils >= 1.5 x 10^9/L; b) Platelet PLT >= 100 x 10^9/L; c) Hemoglobin Hb >= 100g/L; 2) Biochemical examination shall meet the following standards: a) Total bilirubin TBIL = 50ml/min (Cockcroft-Gault formula). 7. Women of childbearing age must have taken reliable contraceptives or had a negative pregnancy test (serum or urine) within 7 days of enrollment and be willing to use an appropriate method of contraception during the trial and 6 months after the last dose of the test drug. In the case of men, consent should be given to use an appropriate method of contraception or to have been surgically sterilized during the trial period and 6 months after the last dose of the experimental drug.
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer (including a mixture of small cell and non-small cell lung cancer); 2. Previous lung cancer treatment, including chemotherapy, radiotherapy, immunotherapy or targeted therapy. 3. Patients with hypertension who are using a combination of two or more antihypertensive drugs; 4. Gene test results showed that patients with known positive EGFR, ALK or ROS1 were not treated with relevant targeted drugs; 5. Has the following cardiovascular disease: II magnitude myocardial ischemia or poor control of myocardial infarction, arrhythmia (including QTc interphase male 450, female 470 ms or ms or higher); According to NYHA standard, III~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5uln), bleeding tendency or receiving thrombolytic therapy or anticoagulant therapy; 7. Two teaspoons or more of hemoptysis per day before enrollment; 8. Clinically significant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic hemorrhoids, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, or vasculitis, etc., occurred within 3 months before enrollment; Patients with any physical signs or history of bleeding, regardless of severity; Patients who had any bleeding or bleeding event =CTCAE3 had unhealed wounds, ulcers or fractures within 4 weeks prior to grouping; 9. Arteriovenous thrombosis (AVT) events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis (DVT) and pulmonary embolism, occurred within 12 months before enrollment; 10. Genetic or acquired bleeding and thrombotic tendencies known to exist (e.g. hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 11. Long-term untreated wounds or fractures (pathological fractures caused by tumors are not included); 12. Had major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment; 13. Urine routine indicated that urine protein >= ++, and confirmed that 24-hour urine protein amount >= 1.0g; 14. Patients with a history or concurrent history of pulmonary interstitial disease; 15. Human immunodeficiency virus (HIV) infection, HIV antibody positive. 16. Has active tuberculosis. 17. Untreated active hepatitis (hepatitis b: HBsAg positive with HBV DNA >1 x 10^3 copy/ml; HCV RNA positive for hepatitis C and abnormal liver function); Co-infection with hepatitis B and C; 18. Has a history of substance abuse and is unable to quit or has a mental disorder; 19. Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment; 20. 5 Present or concurrent with other uncured malignant tumors within 5 years, except cured basal cell carcinoma of skin, carcinoma in situ of cervix and superficial bladder cancer [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1(infiltrating basement membrane)]; 21. Randomized patients to receive over-potent CYP3A4 inhibitor in the first 7 days, or to receive over-potent CYP3A4 inducer in the 12 days before the study; 22. Pregnant or lactating women; persons with fertility who are unwilling or unable to take effective contraceptive measures; 23. The investigator determines that there is a serious risk to patient safety or other conditions that may affect the conduct of the clinical st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mDFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2y DFS%;3y DFS%;mOS;QoL; | — |
Countries
China
Contacts
Public ContactXieTong
Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed