Clinical trial NCT03356600: Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-small-cell Lung Cancer
Official title: The Prospective,Single Arm, Exploratory Clinical Trial of Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-Small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain Metastases
Keywords: Brain Metastases
Lead sponsor: Shanxi Province Cancer Hospital
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: The intracranial disease progression free survival time
timeFrame: tumor assesment every 8 weeks,up to 24 months
Secondary outcomes:
measure: Progression free survival time
timeFrame: evaluated in 24 months since the treatment began
measure: Overall survival
timeFrame: the first day of treatment to death or last survival confirm date ,up to 24 months
measure: Disease control rate
timeFrame: tumor assesment every 8 weeks,up to 24 months
measure: Objective response rate
timeFrame: tumor assesment every 8 weeks,up to 24 months
measure: Dosage changes of dexamethasone
timeFrame: Dosage changes of dexamethasone every 8 weeks,up to 24 months
measure: Volume change rate of cerebral edema
timeFrame: Volume change rate of cerebral edema every 8 weeks,up to 24 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: To observe the safety of therapeutic schedule every 8 weeks,up to 24 months
measure: Cognitive function screening ：Mini-mental state examination (MMSE)
timeFrame: Volume change rate of cerebral edema every 8 weeks,up to 24 months
measure: Executive function testing：trail marking test（TMT）
timeFrame: Volume change rate of cerebral edema every 8 weeks,up to 24 months
measure: Language function detection ：Hopkins verbal learning test-revised（HVLT-R）
timeFrame: these neurocognitive function tests assesment every 8 weeks,up to 24 months
measure: Verbal learning and memory:Hopkins verbal learning test-revised（HVLT-R）
timeFrame: these neurocognitive function tests assesment every 8 weeks,up to 24 months
Other outcomes:
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