Brain metastases from lung adenocarcinoma
Conditions
Interventions
Two: placebo
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. ECOG physical condition score 0~2, or KPS score >=60; 3. Pathologically confirmed advanced lung adenocarcinoma with measurable and evaluated brain metastases (MRI scan >=10mm, meeting RECIST 1.1 criteria); 4. Expected survival >=3 months; 5. Blood routine: ANC >=1.5x10^9/L, Hb >=9 g/dL, PLT >=100x10^9/L; 6. Blood biochemistry: ALT =50ml/min; 7. The patient volunteered to participate in this study and signed written informed consent; 8. Patients with expected compliance were able to follow up the efficacy and adverse reactions as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent presence of other malignant tumors; 2. Pregnant or lactating women; 3. Diseases that can cause hypoxia, such as decompensated heart failure, respiratory failure, recent myocardial infarction, and shock; 4.A variety of factors affecting oral medication (such as inability to swallow, chronic gastritis, chronic diarrhea); 5.Abnormal coagulation function (PT>16 s, APTT>43 S, TT>21 s, Fbg<2 g/L), have bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 6.Severe infection and trauma, major surgical operations, clinical hypotension and hypoxia; 7. Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, which requires insulin; 8. Those who are known to be allergic to this drug component; 9. Participated in other drug clinical trials within 4 weeks; Alcoholics; 11. Uncorrected deficiency of vitamin B12 and folic acid; 12. Illiterate, or mentally handicapped, or mentally ill; 13. Patients with type 1 or type 2 diabetes; 14. Other lesions (e.g., weakness, ileus, etc.) that may reduce or complicate enlistment are identified by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurocognitive function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial Progress Free Survival;Intracranial objective remission rate;Intracranial Disease Control Rate;Overall Survervial; | — |
Countries
China
Contacts
Public ContactZhu Meiling
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed