irAEs
Conditions
Interventions
Single arm:Emaxitinib 4 mg orally 1/day (or tofacitinib 5 mg orally 2/day) for 6 weeks.
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate and provide signed informed consent. 2. Age >=18 years at the time of signing informed consent. 3. Histologically or cytologically confirmed locally advanced or metastatic lung cancer or other solid tumors (clinical diagnosis is acceptable for primary liver cancer). 4. Prior immune checkpoint inhibitor therapy discontinued due to immune-related adverse events (irAEs) (including but not limited to pneumonitis, hepatitis, myocarditis, rash, etc.), with resolution to =3.0×10^9/L ANC >=1.5×10^9/L Platelets >=100×10^9/L Hemoglobin >=9.0 g/dL (2) Biochemistry: Total bilirubin =60 mL/min (3) Coagulation: aPTT and INR 12 weeks. 10. Agreement to use effective contraception by fertile subjects during the study and for 6 months after last treatment. Negative pregnancy test for women of childbearing potential at screening.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the investigational drug or any excipients. 2. Major surgical procedures (excluding needle biopsies) or significant trauma within 4 weeks prior to enrollment, or planned elective surgery during the study. 3. Conditions impairing drug absorption or inability to take oral medication. 4. Persistent toxicities from prior anticancer therapy >CTCAE v5.0 grade 1 (excluding alopecia or other toxicities deemed non-risk by investigators). 5. Symptomatic or uncontrolled CNS/leptomeningeal metastases, including: Progression within 2 months after radiotherapy/local therapy; Investigator-assessed unsuitability for enrollment. 6. Uncontrolled bone metastases with: Imminent/pathological fracture risk; Requirement for recent surgery/radiotherapy; Other critical conditions per investigator judgment. 7. Uncontrolled effusions requiring recurrent drainage (>=1×/month): Pleural/pericardial effusion or ascites. 8. Active infection requiring systemic antimicrobial therapy. 9. Active viral infections or immunodeficiency: HIV infection; Active HBV (HBV DNA >1×10^4 copies/mL or >2000 IU/mL); Active HCV (HCV RNA >1×10^3 copies/mL); Active syphilis. 10. Active autoimmune disease or current steroid use >10 mg/day prednisone equivalent affecting immunotherapy safety. 11. Significant cardiovascular disease: (1) Severe arrhythmia/conduction defects (e.g., ventricular arrhythmia requiring intervention, AV block II-III); QTcF >470 ms; (2) Acute coronary syndrome, CHF, aortic dissection, stroke, DVT, or grade >=3 cardiovascular events within 6 months; (3) Uncontrolled hypertension; (4) Other high-risk cardiac conditions per investigator. 12. Severe pulmonary disease (e.g., ILD, severe COPD, respiratory insufficiency, symptomatic bronchospasm, steroid-requiring radiation pneumonitis). 13. Urinalysis protein >=2+ with 24-hour urine protein >0.5 g. 14. Concurrent participation in another clinical trial or receipt of investigational therapy. 15. Pregnancy/lactation; uncontrolled psychiatric disorders; or other conditions that may:Increase study risk;Compromise protocol compliance;Interfere with results interpretation (per investigator/sponsor judgment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade >=2/3 irAEs; | — |
Countries
China
Contacts
Public ContactXiaodong Jiao
Shanghai Changzheng Hospital
Outcome results
None listed