A Prospective Study of Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in Non-Small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Major Adverse Cardiovascular Events
研究概览
简要总结
This is a prospective, open label, single arm study. A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included . All patients will follow up for at least 1 year. Patients with cardiac adverse reactions after PD-1/PD-L1 immune checkpoint inhibitor treatment at admission or during the subsequently follow-up period will randomly assigned a random number to each patient by computer random sequence. Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Be willing and able to provide written informed consent/assent for the trial;
- •Lung cancer patients whose pathological results confirmed is primary non-small cell lung cancer, stage III~IV;
- •Patients received with ICIs treatment, including anti-PD-1 or anti-PD-L1 for at least two courses;
排除标准
- •Patients who do not have pathological diagnosis;
- •Patients who can't finish the follow-up;
- •The anti-PD-1, anti-PD-L1 therapy was less than two courses;
- •Patients whose cancer diagnosed with small cell lung cancer.
研究组 & 干预措施
observation group
A total of 300 patients are expected to include in this group. And the cardiac adverse reactions related to immune checkpoint inhibitor will be observed.
干预措施: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor (Drug)
结局指标
主要结局
Major Adverse Cardiovascular Events
时间窗: 1 year
a) Primary Outcome is Major Adverse Cardiovascular Events（MACE）related to ICIs，includes: cardiovascular death, myocardial infarction(nonfatal), stroke(nonfatal), heart failure that caused readmission
次要结局
- Common Terminology Criteria for Adverse Events (CTCAE)(1 year)
- examination indexes(1 year)
- All cause of death(1 year)
研究者
Xumin Hou
Chief physician
Shanghai Chest Hospital