Immune checkpoint inhibitor-associated myocarditis
Conditions
Interventions
Treatment Group:Tofaciib and Mycophenolate Mofetil
Control Group:Tofaciib
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years old. 2. Patients diagnosed with malignant tumors by histopathology or cytology and have received at least one cycle of immune checkpoint inhibitor treatment. 3. Diagnosed as immune checkpoint inhibitor (ICI)-related myocarditis according to the "Clinical Practice Guidelines for Immune Checkpoint Inhibitor-Associated Myocarditis" in 2023 [11-12]. 4. Diagnosed as glucocorticoid-resistant ICI-related myocarditis according to the "2022 ESC Guidelines on Cardio-Oncology" [8]: after receiving at least 3 days of standard-dose glucocorticoid treatment, any of the following occurs: (1) no significant reduction in cTn (reduction less than 50% of the peak value); (2) atrioventricular block, ventricular arrhythmia or left ventricular dysfunction persists. 5. No absolute contraindications to glucocorticoid treatment. 6. No absolute contraindications to tofacitinib treatment. 7. Able to comply with the protocol during the study period. 8. Provide written informed consent before entering the study, and the patient has been informed that they can withdraw from the study at any time without any loss. 9. Women of childbearing age must have a negative urine or serum pregnancy test within 7 days before enrollment and must agree to use highly effective contraceptive measures during the study and for at least 120 days after the last dose (including tofacitinib and glucocorticoids). 10. Unsterilized men must agree to use highly effective contraceptive measures during the study and for at least 120 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with tofaciib or any other JAK inhibitor. 2. Patients with active autoimmune disease or who have a history of autoimmune disease but may relapse. 3. Patients with gastrointestinal bleeding within the first two weeks of enrollment, or those with high blood risk judged by the investigators. 4. There are uncontrollable systemic diseases including diabetes, hypertension, etc. 5. Severe chronic or active infections that require systemic antibiotics, antifungal drugs, or antiviral treatment, including tuberculosis, HIV infection, etc. 6. Untreated chronic hepatitis B or chronic HBV carriers with hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or hepatitis C virus (HCV) RNA positive patients should be excluded. 7. Allergic to any investigational drug ingredient. 8. Has undergone allogeneic stem cell transplantation or organ transplantation. 9. Individuals with a history of uncontrolled epilepsy, central nervous system disease, or mental disorders will be assessed by the researcher to determine whether their clinical severity hinders the signing of informed consent forms or affects the patient's adherence to oral medication. 10. There is an underlying medical condition that the investigator considers to be detrimental to the study of drug administration or to the interpretation of drug toxicity or adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time when the glucocorticoid was reduced to the lowest dose (prednisone 10mg or methylprednisolone 8mg); | — |
Secondary
| Measure | Time frame |
|---|---|
| The 3-month all-cause mortality rate;The 6-month all-cause mortality rate;Median progression-free survival (PFS);Overall survival (OS) ; | — |
Countries
China
Contacts
Public ContactWang Yan
Zhongshan Hospital, Fudan University
Outcome results
None listed