NCT03356600Unknown2 期
The Prospective,Single Arm, Exploratory Clinical Trial of Apatinib Plus Radiotherapy for Patients With Brain Metastases From Non-Small-cell Lung Cancer
Shanxi Province Cancer Hospital0 个研究点目标入组 44 人开始时间: 2017年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 44
- 主要终点
- The intracranial disease progression free survival time
研究概览
简要总结
To observe the effectiveness and safety of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Apatinib plus radiotherapy
Experimental
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.
干预措施: Apatinib plus radiotherapy (Combination Product)
结局指标
主要结局
The intracranial disease progression free survival time
时间窗: tumor assesment every 8 weeks,up to 24 months
To observe the intracranial disease progression free survival time of apatinib combined with radiotherapy for brain metastasis from non-small cell lung cancer patients
次要结局
- Progression free survival time(evaluated in 24 months since the treatment began)
- Overall survival(the first day of treatment to death or last survival confirm date ,up to 24 months)
- Disease control rate(tumor assesment every 8 weeks,up to 24 months)
- Objective response rate(tumor assesment every 8 weeks,up to 24 months)
- Dosage changes of dexamethasone(Dosage changes of dexamethasone every 8 weeks,up to 24 months)
- Volume change rate of cerebral edema(Volume change rate of cerebral edema every 8 weeks,up to 24 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(To observe the safety of therapeutic schedule every 8 weeks,up to 24 months)
- Cognitive function screening ：Mini-mental state examination (MMSE)(Volume change rate of cerebral edema every 8 weeks,up to 24 months)
- Executive function testing：trail marking test（TMT）(Volume change rate of cerebral edema every 8 weeks,up to 24 months)
- Language function detection ：Hopkins verbal learning test-revised（HVLT-R）(these neurocognitive function tests assesment every 8 weeks,up to 24 months)
- Verbal learning and memory:Hopkins verbal learning test-revised（HVLT-R）(these neurocognitive function tests assesment every 8 weeks,up to 24 months)
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