immune checkpoint inhibitor-associated myocarditis
Conditions
Interventions
Conventional treatment group:Glucocorticoids +/- immunosuppressive or biological agents
Conventional treatment + rucotinib treatment group:Conventional therapy + rucotinib
Conventional treatment + rucotinib + Chinese medicine treatment group:Conventional therapy + rucotinib + Chinese medicine treatment
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of malignancy confirmed by cytology or histopathology; 2. Presence of ICIAM after treatment with ICIs meets diagnostic criteria for severe/critical illness; 3. 18 years <= age <= 80 years.
Exclusion criteria
Exclusion criteria: 1.There is clear evidence suggesting cardiac injury from non-ICIs; 2.Combination of severe adverse immune reactions in other organs; 3.Has been treated with glucocorticoids for more than 1 week; 4.Clinically severe pulmonary/hepatic/renal impairment or with severe comorbidities such as acute cardiac infarction, new-onset cerebral infarction; 5.Serious life-threatening conditions such as hemodynamically unstable shock requiring vasoactive drug support, ventilator-assisted respiration requiring endotracheal intubation, and recurrent episodes of ventricular fibrillation requiring defibrillation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of MACE within 28 days;Changes in Chinese Medicine Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| cTn return to normal time;Clinical remission rate;Duration of invasive ventilator-assisted breathing, cardiovascular support;Incidence of infection;Mortality within 3 months; | — |
Countries
China
Contacts
Public ContactXu Yan
Peking Union Medical College Hospital
Outcome results
None listed