Immune checkpoint inhibitor-associated myocarditis
Conditions
Interventions
Tofaciib Group:Tofacatib sustained-release tablet 11mg, once daily, one tablet per day
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 with histologically or cytopathologically confirmed malignant tumors who have received at least one cycle of checkpoint inhibitor therapy. 3) According to the 2023 Clinical Diagnosis and Treatment Recommendations for Immune Checkpoint Inhibitor Related Cardiomyositis, it is diagnosed as ICIs related myocarditis. 4) Glucocorticoid-resistant ICIs-associated myocarditis was diagnosed according to the 2022 ESC Guidelines for Cancer Cardiology: after receiving at least 3 days of standard dose glucocorticoid treatment, any of the following situations occur: ? cTn does not significantly decrease (the decrease is less than 50% of the peak); ? Atrioventricular block, ventricular arrhythmia, or left ventricular dysfunction still persist. 5) Absolute contraindications of non-glucocorticoid therapy. 6) There is no absolute contraindication for tofaciib treatment. 7) Be able to adhere to the protocol during the study. 8) Provide written informed consent before entering the study, and the patient is aware that they can withdraw from the study at any time without any loss. 9) Women with fertility must have a negative pregnancy test in their urine or serum within 7 days prior to enrollment, and must agree to take efficient contraceptive measures during the study period and at least 120 days after the last dose (including tofacitinib and glucocorticoids). 10) Unsterilized males must agree to adopt efficient contraceptive measures during the study period and 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 |
|---|---|
| All-cause mortality within three months; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality within six months;OS;PFS; | — |
Countries
China
Contacts
Public ContactWang Yan
Zhongshan Hospital, Fudan University
Outcome results
None listed