Adverse Reactions, Cardiac Event, Immune Checkpoint Inhibitor, Non-Small Cell Lung Cancer Patients
Conditions
Brief summary
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）.
Interventions
DRUGrenin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor
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）
Sponsors
Shanghai Chest Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Be willing and able to provide written informed consent/assent for the trial; 2. Lung cancer patients whose pathological results confirmed is primary non-small cell lung cancer, stage III\ IV; 3. Patients received with ICIs treatment, including anti-PD-1 or anti-PD-L1 for at least two courses;
Exclusion criteria
1. Patients who do not have pathological diagnosis; 2. Patients who can't finish the follow-up; 3. The anti-PD-1, anti-PD-L1 therapy was less than two courses; 4. Patients whose cancer diagnosed with small cell lung cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Common Terminology Criteria for Adverse Events (CTCAE) | 1 year | Common Terminology Criteria for Adverse Events (CTCAE) related to ICIs, includes: arrhythmia, cardiogenic chest pain, valvular heart disease, cardiomyopathy, myocardial pericardial disease |
| All cause of death | 1 year | every reason that cause patient's death after ICIs treatment |
| examination indexes | 1 year | The examination indexes that related to myocardial damage |
Contacts
Primary ContactYunhua Xu
Outcome results
None listed