Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients, 18-75 years old; 2.PS02 3. Patients with lung adenocarcinoma confirmed by histology or cytology and detected EGFR mutation; 4. Patients with life expectancy greater than 12 weeks; 5. Patients willing to sign informed consent; 6. Patients with evaluable lesions in the brain should have more than 3 lesions, and the largest lesions should be more than 1cm; 7. Patients who can follow the research and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with any unstable systemic diseases (including active infection, poor control of hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic diseases); 2. Patients who have received EGFR inhibitors (including small molecule or monoclonal antibody treatment) and systematic anti-tumor treatment before treatment; 3. Patients who received radiotherapy for brain metastases; 4. Any patients with obvious ocular abnormalities, especially severe dry eye syndrome, dry keratoconjunctivitis, severe exposure keratitis or other diseases that may increase epithelial damage; 5. Patients who are unable to receive oral administration, need intravenous high energy nutrition, have previously had surgery affecting absorption or have active peptic ulcer; 6. Lactating women; 7. Granulocyte count is less than 1.5 * 10^9 / L, platelet count is less than 75 * 10^9 / L; 8. Serum bilirubin was 1.5 times higher than the upper limit of normal; 9. AST and ALT were more than 2 times of the upper limit of normal value, and 5 times of the upper limit of normal value in case of liver metastasis. Serum creatinine was 1.5 times higher than the upper limit of normal value, or creatinine clearance rate was less than 50ml / min; 10. Patients with history of hemoptysis (daily blood volume more than 5ml); 11. The mass is central and close to the large blood vessels.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size;Control time of intracranial metastatic FOCI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate of brain metastasis;Total time of disease progression;Six-month and one-year survival rates;Relationship between therapeutic effect and gene EGFR EXON 18-21 mutation;Progression-free intracranial survival time after progression;Non-progressive extracranial survival time;Objective intracranial remission rate;Safety and tolerability; | — |
Countries
China
Contacts
Department 1 of Oncology, Maoming People's Hospital