NCT04912128已完成不适用
Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases.
详细描述
This is a retrospective study. The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases. Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1~14, 21d/cycle. Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions;
- •Patients aged between 18 -80 years; with expected survival time>3 months.
- •Patients with no more than 5 brain metastases
- •Patients with normal organ function within 7 days prior to treatment, the following criteria are met:
- •blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;
排除标准
- •Patients who had previously used antiangiogenic agents within 1 month;
- •Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
- •Patient with lung squamous cell carcinoma that involved pulmonary hilar, or non-small cell lung cancer with hemoptysis;
- •Patients with cerebral infarction and cerebral hemorrhage;
- •Patients without perilesional edema；
- •Patients with more than grade 2 (NCI-CTCAE v4.0) acute toxicity reaction due to any previous treatment.
- •Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.);
- •Patients with visceral dissemination or severe symptoms, which could cause death in short term;
- •Patients with any other severe and/or uncontrolled disease;
- •Patients who received a surgery, a biopsy or a significant traumatic injury within 1 month;
- •Patients with any signs or medical history of bleeding, unhealed wounds, ulcers or fractures, regardless of the severity;
- •Patients underwent artery or venous thrombotic events within 2 months, such as deep vein thrombosis and pulmonary embolism;
- •Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
- •Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；
研究组 & 干预措施
Anlotinib group
Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1~14, 21d/cycle. All patients received SBRT for brain metastases.
干预措施: Anlotinib (Drug)
结局指标
主要结局
PFS
时间窗: 1 years
progression-free survival
次要结局
- OS(1 years)
- iORR(3 months)
- ORR(3 months)
- DCR(3 months)
- iPFS(3 months)
研究者
研究点 (1)
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