Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 主要终点
- Leptomeningeal Metastasis Overall survival
研究概览
简要总结
The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old
- •Pathologically proven non-small cell lung cancer
- •Karnofsky performance status ≥ 40
- •LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
- •No severe abnormal liver and kidney function;
- •Patients have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Evidence of bleeding diathesis or serious infection
- •Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- •Pregnant or lactating women
研究组 & 干预措施
Endostatin Therapy for NSCLC of LM
Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer
Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles.
intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days.
Targeted drugs for non-small cell lung cancer:
EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
干预措施: Recombinant Human Endostatin (Drug)
Endostatin Therapy for NSCLC of LM
Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer
Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles.
intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days.
Targeted drugs for non-small cell lung cancer:
EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
干预措施: intrathcal methotrexate (Drug)
Endostatin Therapy for NSCLC of LM
Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer
Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles.
intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days.
Targeted drugs for non-small cell lung cancer:
EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
干预措施: Targeted drugs for non-small cell lung cancer (Drug)
结局指标
主要结局
Leptomeningeal Metastasis Overall survival
时间窗: 36 months
Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up
Neurological Progression Free Survival
时间窗: 36 months
From the start of treatment until central nervous system metastase progression or death due to any cause
The incidence of adverse reactions
时间窗: 36 months
From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)
次要结局
- Objective Response Rate(36 months)
- Neurological assessment(36 months)
- progression-free survival(36 months)
- Overall survival(36 months)
研究者
Hui Bu
Study Principal Investigator
Hebei Medical University