Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer

Study Purpose

To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Aged 18 to 75 years old, males or females;. 2. According to pathological and histological，the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations; 3. Subjects failed first-line standard chemotherapy ; 4. Subjects expected survival of more than 3 months; 5. Eastern Cooperative Oncology Group performance status :0-2 points; 6. The main organ function is normal, that is to meet the following standards:(1) Blood routine examination meets the following standards a. Hemoglobin ≥90 g/L；b. Absolute Neutrophil Count≥1.5×10^9/L； c. Platelet ≥80×10^9/L； (2)Blood biochemistry examination meets the following standards a.Total Bilirubin <1.5 times the upper normal limit；b.Glutamic transaminase <2.5 times the upper normal limit, glutamic-oxalacetic transaminase <2.5 times the upper normal limit， For patients with liver metastasis ,the Glutamic transaminase and glutamic-oxalacetic transaminase index is less than 5 times the upper normal limit c.Serum Cr was less than 1.25 times the upper normal limit 7. Women of reproductive age must undergo urine tests to eliminate the possibility of pregnancy.During the period of treatment and within 8 weeks after the treatment, the subjects voluntarily adopted appropriate methods of contraception . 8. Subjects volunteered to participate in this study and signed informed consent

Exclusion Criteria:

1. Patients with meningeal metastasis; 2. Patients with intracranial stroke; 3. Previous toxicity associated with chemotherapy and / or radiotherapy persisted; 4. Radiological evidence indicates the presence of an empty or necrotic tumor; 5. Radiological evidence indicates the presence of a central tumor invading large blood vessels; 6. Patients need to be treated with anticoagulants or antiplatelet drugs; 7. The subjects with abnormal coagulation function and bleeding tendency (INR>1.5×ULN、APTT>1.5×ULN);during the past 6 months, the subjects experienced severe thrombosis or clinically related severe bleeding events;In the past 3 months, clinically significant hemoptysis occurred;the subjects had inherited bleeding or thrombosis tendency; 8. Subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs; 9. Other investigators believe that patients are not eligible for inclusion

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03356600
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanxi Province Cancer Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases

Arms & Interventions

Arms

Experimental: Apatinib plus radiotherapy

Apatinib: Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily. After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg. Radiotherapy: The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy.