Status:
UNKNOWN
Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer
Lead Sponsor:
Shanxi Province Cancer Hospital
Conditions:
Brain Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
Eligibility Criteria
Inclusion
- Aged 18 to 75 years old, males or females;.
- According to pathological and histological，the subjects were diagnosed with wild-type non-small-cell lung cancer patients from brain metastasis examinations;
- Subjects failed first-line standard chemotherapy ;
- Subjects expected survival of more than 3 months;
- Eastern Cooperative Oncology Group performance status :0-2 points;
- 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
- 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 .
- Subjects volunteered to participate in this study and signed informed consent
Exclusion
- Patients with meningeal metastasis;
- Patients with intracranial stroke;
- Previous toxicity associated with chemotherapy and / or radiotherapy persisted;
- Radiological evidence indicates the presence of an empty or necrotic tumor;
- Radiological evidence indicates the presence of a central tumor invading large blood vessels;
- Patients need to be treated with anticoagulants or antiplatelet drugs;
- 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;
- Subjects with high blood pressure and whose blood pressure can not be reduced to normal range by antihypertensive drugs;
- Other investigators believe that patients are not eligible for inclusion
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03356600
Start Date
December 1 2017
End Date
October 1 2019
Last Update
December 11 2017
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