non-small cell lung cancer
Conditions
Interventions
Case series:surgery+anlotinib(The drug dose is taken on a continuous daily fasting dose of 12 mg/d of anlotinib hydrochloride for 2 weeks, and then administration is stopped for 1 week, namely 3 weeks
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent has been signed; 2. Be able to comply with research program and follow up processes; 3. The patient's age is more than 18 years old; 4. Histology or cytology diagnosis is confirmed to be NSCLC; chest enhanced CT, liver and adrenal CT, cranial magnetic resonance (MRI), PET-CT/ bone scintigraphy, and so on support the stage of IA (according to the eighth edition of the UICC 2016 staging criteria) and the patients have not received any anti-tumor treatment; 5. The diameter of the tumor is less than 3cm; 6. Be eligible for receiving radical resection, with negative margin and margin > 2 cm or > tumor diameter, no lymph node metastasis, no pleural depression surgery patients; 7. Patients must have measurable lesions (according to RECIST 1 standard); 8. Physical status Eastern Cooperative Oncology Group (ECOG) score is 0~1; 9. Life expectancy is at least 40 weeks; 10. The following laboratory tests should be performed within 7 days before the first drug administration to confirm that the patient's bone marrow, liver and kidney functions meet the requirements of the study: (1) Hemoglobin is equal to or more than 9 g/dL (or can be maintained or exceeded by transfusion); (2) The absolute count of neutrophils (ANC) is more than 1.5 x 10^9; (3) The platelet count is equal to or more than 100 x 10 ^9/mm ^3; (4) Total bilirubin is equal to or less than 1.5 times of the upper limit of normal value; (5) Alanine aminotransferase and aspartate aminotransferase are equal to or less than 2.5 times of the normal upper limit; (5) Creatinine is equal to or less than 1.5 times of the normal upper limit, and the creatinine clearance rate is more than 60ml/min; (6) The international normalized ratio of prothrombin time (INR) is equal to or less than 1.5, and the partial thromboplastin time (APTT) is equal to or less than 1.5 times of upper limit of the normal value. Patients receiving full or parenteral anticoagulant therapy should be able to stabilize the dose of anticoagulants before entering the clinical study for at least 2 weeks, and the results of the coagulation test could be entered into clinical trials within the limits of local treatment; (7) Women of childbearing age must undergo pregnancy tests within 7 days before the initiation of treatment, and the results are negative; (8) Reliable methods of contraception must be used in men and women of the right age until 30 days after withdrawal from the study before entering the trial. Reliable contraceptive methods will be determined by the principal investigator or designated person.
Exclusion criteria
Exclusion criteria: 1. Have received any systemic anticancer treatment for NSCLC, including cytotoxic drugs, targeted drugs, and experimental therapies; 2. Have received surgical treatment for NSCLC; 3. Have received local radiotherapy for NSCLC; 4. Patients suffering from other cancers except NSCLC. Except for cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor, including Ta and Tis in five years before the start of the study; 5. Any unstable systemic disease (including active infection, non-controlled hypertension, unstable angina, angina pectoris in the last 3 months, congestive heart failure (= the New York Heart Association [NYHA] II), myocardial infarction (6 months before grouping), and serious arrhythmia, liver, kidney or metabolic diseases caused by drugs; 6. Once or at present suffering from interstitial lung disease; 7. Eye inflammation or eye infection that is not completely controlled, or any condition that may cause eye diseases; 8. Known human immunodeficiency virus (HIV) infection; 9. Drug allergy to any kind in the research (mainly for anlotinib); 10. Patients who undergo major surgery or severe trauma within 2 months before the first medication; 11. Any situation of poor absorption; 12. Women who are pregnant or lactation; 13. Other situations that researchers believe to be not suitable for entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;overall survival;relapse rate;Disease-free Survival; | — |
Countries
China
Contacts
Public ContactZhang Peng
Shanghai Pulmonary Hospital
Outcome results
None listed