An observational study in Adverse Reactions, Immune Checkpoint Inhibitor and Non-Small Cell Lung Cancer Patients, sponsored by Shanghai Chest Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-16.
Sponsored by Shanghai Chest Hospital · Observational
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）.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 300 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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. And then the basic information and the examination results will be collected.
Exclusion Criteria:
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.
Drug: renin-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）
Major Adverse Cardiovascular Events
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
Time frame: 1 year
Common Terminology Criteria for Adverse Events (CTCAE)
Common Terminology Criteria for Adverse Events (CTCAE) related to ICIs, includes: arrhythmia, cardiogenic chest pain, valvular heart disease, cardiomyopathy, myocardial pericardial disease
Time frame: 1 year
All cause of death
every reason that cause patient's death after ICIs treatment
Time frame: 1 year
examination indexes
The examination indexes that related to myocardial damage
Time frame: 1 year
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Shanghai Chest Hospital