Lung Cancer
Conditions
Interventions
Sponsors
Huadong Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, male or female; 2. Patients with EGFR mutation positive stage IIB to IIIA NSCLC confirmed by histopathology and / or cytology; 3. Patients with normal function of main organs meet the following requirements: (1) Blood routine examination should meet the following requirements (no blood transfusion within 14 days) HB >= 90g/L ANC >= 1.5 x 10^9/L PLT >= 80 x 10^9/L (2) Biochemical tests should meet the following standards: Serum Cr <= 1 x The upper limit of normal value (ULN), endogenous creatinine clearance rate = 50ml / min (Cockcroft Gault formula); 4. Patients with an estimated survival time of more than 3 months; 5. Patients who are planned to be treated with amitinib; 6. The patients who voluntarily joined the study signed the informed consent; 7. Women of childbearing age must have negative pregnancy test (serum or urine) results within 7 days before enrollment, and voluntarily use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of amitinib; For men, it should be surgical sterilization, or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of amitinib.
Exclusion criteria
Exclusion criteria: 1. Patients with hypertension, whose systolic blood pressure (SBP) > 140 mmHg / diastolic blood pressure (DBP) > 90 mmHg, had coronary heart disease, arrhythmia (including QTc interval prolongation, male > 450 ms, female > 470 MS) and cardiac insufficiency; 2. Patients with multiple factors affecting oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 3. Patients with abnormal coagulation function (INR > 1.5) x ULNAPTT>1.5 x ULN) with bleeding tendency; 4. Patients with symptomatic central nervous system metastasis; 5. Pregnant or lactating women; 6. Other patients considered unsuitable by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| radical resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Remission;Objective Response Rate;disease free survival;overall survival;quality of life;safety profile;explorative biomarkers; | — |
Countries
China
Contacts
Public ContactYingjie Lu
Huadong Hospital
Outcome results
None listed