Recruiting
PHASE4
INTERVENTIONAL
NCT06178146
Thymosin Alpha-1 for irAE Secondary to ICIs
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Thymosin alpha-1 (TĪ±-1) has shown clinical benefits in patients whose immune functions are severely compromised or ineffective. Therefore, this study is attempted to explore whether TĪ±-1 could be used as a therapeutic option for the treatment of immune-related adverse events (irAEs).
Interventions
Name:
Thymosin Alpha1
Type:
DRUG
Description:
Based on the conventional treatment, subcutaneous injection of TĪ±-1 (1.6 mg, qd) in Week 1; and in Week 2, subcutaneous injection of thymalfasin 1.6 mg, 3 times a week, followed by twice a week for 1 month since Week 3.
Name:
Immunosuppressant
Type:
DRUG
Description:
Grade 2 irAEs: corticosteroid alone Grade 3 and above irAEs: corticosteroids combined with other immunosuppressants Steroid-refractory irAE: After 48-72 hours of systemic steroid therapy, the symptoms do not improve or worsen, and the second-line immunosuppressant therapy is adopted.
Primary Outcomes
Measure:
Symptoms relieving rate
TimeFrame:
within one week after the first injection of thymalfasin.
Description:
The proportion of immune-related adverse events reduced by at least 1 grade within 1 week after the first injection of thymalfasin.
Trial Information
NCT ID
NCT06178146
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Jun Wang
Last Updated
December 15, 2025