Non-small cell lung cancer with brain metastases
Conditions
Interventions
Experimental group:Anlotinib combined with whole brain radiotherapy
Sponsors
Chengdu Fifth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-75 years old, male or female 2. EGFR wild-type non-small cell lung cancer with brain metastases not suitable for gamma knife or stereotactic body radiation therapy 3. Expected survival time =3 months 4. The PS score was 0-2 5. Adequate liver and kidney function is required to meet the following criteria a) hemoglobin =90g/L b) absolute neutrophil count =1.5×10^9/L c) platelet count =80×10^9/L 6. Blood biochemical tests meet the following criteria a) Total bilirubin < 1.5 times the upper limit of normal b) alanine aminotransferase < 2.5 times the upper limit of normal and glutamate oxaloacetate aminotransferase < 2.5 times the upper limit of normal (for patients with liver metastases, glutamate aminotransferase and glutamate oxaloacetate aminotransferase are less than 5 times the upper limit of normal) c) Serum Cr less than 1.25 times the upper limit of normal 7. Women of childbearing age should undergo a pregnancy test to rule out pregnancy; Appropriate contraception should be used during and for 8 weeks after anlotinib treatment 8. All subjects voluntarily participated in the study and signed the informed consent
Exclusion criteria
Exclusion criteria: 1. Imaging (CT or MRI) shows that the tumor has invaded the large blood vessels of the central tumor; Or showed obvious cavitary or necrotizing tumors in the lung 2. Uncontrolled hypertension (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg despite optimal medical therapy) 3. Abnormal coagulation function (INR >1.5 or prothrombin time (PT) >ULN+4 seconds or APTT>1.5ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy 4. Patients had obvious hemoptysis or 2.5ml or more hemoptysis per day within 2 months before enrollment 5. arterial/venous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism 6. There are obvious factors that affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction 7. Urine routine showed urine protein =++, or confirmed 24-hour urine protein =2.0g 8. Previous or concurrent history of other uncured malignant tumors, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer 9. Patients treated with a potent CYP3A4 inhibitor within 7 days before enrollment or with a potent CYP3A4 inducer within 12 days before enrollment 10. Pregnant or lactating women; Patients of childbearing potential who are unwilling or unable to use effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| iORR;iDCR;Toxicity;OS; | — |
Countries
China
Contacts
Public ContactLi Shuai
Chengdu Fifth People's Hospital
Outcome results
None listed