Thymosin Alpha-1 for irAE Secondary to ICIs

PHASE4RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

November 30, 2024

Study Completion Date

April 30, 2025

Conditions
IrAE
Interventions
DRUG

Thymosin Alpha1

Based on the conventional treatment, subcutaneous injection of Tα-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.

DRUG

Immunosuppressant

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.

Trial Locations (1)

250014

RECRUITING

The first affiliated hospital of Shandong First Medical University, Jinan

All Listed Sponsors
lead

Jun Wang

OTHER