Immune-mediated Liver Injury from Checkpoint Inhibitors, ILICI
Conditions
Interventions
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with malignant tumors who develop grade 4 liver injury after receiving immune checkpoint inhibitors; 2. Patients who are resistant to hormones and have poor response to second-line immunosuppressive therapy (specifically, those whose liver function does not significantly improve after 3 days of glucocorticoid treatment, and still shows no significant improvement after 7 days of adjustment to second-line immunosuppressive therapy); 3. ECOG PS score <= 2; 4. Age between 18 and 65 years old, male or female; 5. Willing to sign The informed consent form
Exclusion criteria
Exclusion criteria: 1. Severe infection and active tuberculosis; 2. Uncontrolled diabetes and hypertension; 3. Multiple organ failure; 4. End-stage malignant tumors; 5. Allergic to sirolimus and its components; 6. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alanine Aminotransferase, ALT;Total Bilirubin, TBIL; | — |
Secondary
| Measure | Time frame |
|---|---|
| Aspartate Aminotransferase, AST;Gamma-Glutamyl Transferase, GGT;Alkaline Phosphatase, ALP;International Normalized Ratio, INR; | — |
Countries
China
Contacts
Public ContactZhen Xu
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed