NCT05385185招募中2 期
Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 3-month overall survival rate
研究概览
简要总结
immune checkpoint inhibitor combined with recombinant human endostatin can improve the 3-month OS rate of leptomeningeal metastasis of lung cancer, and the combination is safe
详细描述
We will recruit 20 patients with leptomeningeal metastases from lung cancer.
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 ≥18 years old, gender unlimited;
- •A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis;
- •A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging;
- •Proper organ function (neutrophil count ≥1.5× 109 /L, platelet count ≥100× 109 /L, hemoglobin concentration ≥90g/L, serum transaminase concentration ≤2.5 times the limit of normal value, serum creatinine concentration ≤ 1.5 times the upper limit of normal value, proteinuria ≤1+)
- •Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone
- •Signed the informed consent and was willing to follow the experimental protocol and follow-up
排除标准
- •Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation
- •Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes;
- •Be allergic to PD-1 inhibitor and recombinant human endostatin
- •The female patient planned to be pregnant, was pregnant and lactating -
研究组 & 干预措施
Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin
Experimental
Camrelizumab 200mg intravenously, once every 21 days or envafolimab 150mg subcutaneous injection,once a week Endostatin 30mg/d was administered intravenously for 7 days (d1-d7). The interval between Endostatin and next was 2 weeks.
干预措施: Camrelizumab or envafolimab (Drug)
结局指标
主要结局
3-month overall survival rate
时间窗: 3 month
The 3-month survival rate after treatment
safty
时间窗: 2 years
Adverse events related to treatment
次要结局
- iPFS(2 years)
- extracranial PFS(2 years)
- DCR(2 years)
研究者
Hui Bu
The department of neurology
Hebei Medical University
研究点 (1)
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