Immune myocarditis, immune enteritis, immune myositis arthritis, immune skin reactions, immune hepatitis, etc
Conditions
Interventions
Experimental group:Tofacitinib citrate tablets: 5-10 mg, BID PO, until symptoms improve to less than grade 1 or treatment is ineffective, with a maximum duration of use not exceeding 30 days. Other tr
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Inclusion criteria: Age = 18 years old. 2.ECOG physical status score 0-2; 3.Patients with solid tumors treated with immune checkpoint inhibitors (ICIs). 4.The ICIs treatment process can be used alone or in combination (including but not limited to radiotherapy, chemotherapy, targeted therapy, etc.). 5.The patient is currently diagnosed with hormone-resistant or hormone-dependent immune-related adverse reactions (such as immune skin reactions, immune colitis, immune arthritis or myositis, immune myocarditis, immune pneumonia, etc.). 6.The patient still has certain organ and bone marrow functions: Hemoglobin value =90g/L, neutrophil count: =1.0×10^9/L, platelet count =75×10^9/L; Liver Function: Serum total bilirubin =1.5× upper limit of normal (UNL), aspartate transferase =3×UNL, alanine transferase =3×UNL; Renal Function: Serum creatinine =1.5×UNL or creatinine clearance rate =50ml/min; Coagulation Function: All INR, APTT and PT =1.5×UNL; Or patients who have been evaluated and determined by researchers to have sufficient organ function. 7.All potentially fertile women must have negative results from the serum pregnancy test during the screening period, and must take reliable contraceptive measures from the time of signing the informed consent form until 3 months after the last administration; 8.The subjects voluntarily joined this study, signed the informed consent form before the screening procedure, had good compliance and cooperated with the safety follow-up. 9.Patients who have contraindications for hormone use or who have experienced related adverse reactions after hormone use and refuse to continue hormone therapy.
Exclusion criteria
Exclusion criteria: 1.Individuals with allergic diseases, a history of severe drug allergies, or potential allergies to tofacitinib or its drug components; 2.Diagnosed with thrombotic events within the first 3 months of enrollment, excluding superficial vein thrombosis (such as deep vein thrombosis, pulmonary embolism, embolic stroke, myocardial infarction, or peripheral arterial insufficiency); 3.Patients with severe heart, liver, kidney and systemic diseases not related to irAE; 4.The patient has active pulmonary tuberculosis and the subject received live vaccination during the illness period; 5.The patient has uncontrollable infectious diseases; 6.Patients with moderate to severe heart failure (NYNA classification III/IV); 7.Received JAK inhibitor treatment before enrollment; 8.Excessive use of CYP3A4 inducers (such as ketoconazole) within 7 days prior to enrollment. 9.Intravenous injection of biologics for the treatment of patients with other baseline autoimmune diseases; 10.Pregnant or lactating women, as well as men and women who are unwilling to take contraceptive measures; 11.Mental illnesses that hinder research compliance; 12.Researchers believe that participants who are not suitable to participate in this study should be excluded from the study. For example, if the researchers determine that there are other factors that may cause the study to be terminated midway, such as other serious illnesses (including mental illnesses) that require concomitant treatment, serious laboratory examination abnormalities, and family or social factors that may affect the safety of the participants, or the collection of data and samples. 13.Hepatitis B B surface antigen (HBsAg) or hepatitis B B core antibody (HBcAb) positive, hepatitis B virus (HBV) deoxyribonucleic acid (DNA) higher than 500IU/mL or 1000 copies (cps)/mL, hepatitis C antibody (HCV Ab) positive, hepatitis C virus (HCV) - ribonucleic acid (RNA) level higher than the upper limit of the normal value of the testing unit, anti HIV antibody positive, active syphilis, and any of the above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event (AE) response rate during the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median number of days required for clinical remission of immune-related adverse reactions to decrease by one grade;Clinical response rate of immune-related adverse events (irAEs);Achievement of immune-related adverse event (irAE) clinical remission to Grade =1; | — |
Countries
China
Contacts
Public ContactChen Yu
Fujian Cancer Hospital
Outcome results
None listed