Immune checkpoint inhibitors related myocarditis
Conditions
Interventions
Immune rechallenging group (Immune checkpoint inhibitor):None
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Over 18 years old. 2) Patients with histologically or cytopathologically confirmed malignant tumors who have received at least one cycle of checkpoint inhibitor therapy. 3) A clear diagnosis of ICIS-associated myocarditis was made according to the 2023 Guidelines for the Management of Toxicity Associated with Immune Checkpoint Inhibitors, with a grade of G1 or G2. 4) To evaluate the recovery of myocarditis treatment according to the 2022 ESC Guidelines for Cancer Cardiology. 5) There is no alternative to antitumor therapy. 6) Be able to adhere to the protocol during the study. 7)Provide written informed consent before entering the study, and the patient has understood that he can withdraw from the study at any time during the study without any loss.
Exclusion criteria
Exclusion criteria: 1) Patients with active autoimmune disease or who have a history of autoimmune disease but may relapse. 2) Patients with myocarditis who have not yet recovered from treatment. 3) Patients with alternative antitumor treatments. 4) Uncontrollable systemic diseases including diabetes, high blood pressure, etc. 5) Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral treatment, including tuberculosis, HIV infection, etc. 6) Patients with 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 should be excluded. 7) Allergic to any investigational drug ingredient. 8) Have had allogeneic stem cell transplantation or organ transplantation. 9) For patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity of the disorder prevents the signing of informed consent or affects the patient's compliance with oral medications. 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 |
|---|---|
| Tumor control rate in three months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Overall survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactWangyan
Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China
Outcome results
None listed