Nutritional + Usual Corticosteroids Randomized Trial for Immune-Related pneumoniA - Therapeutic Utilization Evaluation
Summary
This is a prospective, single-center, open-label, randomized controlled clinical trial evaluating whether the addition of a nutritional therapy regimen (Spirulina-Bifidobacterium capsules, fish oil-grape seed-blueberry soft capsules, and Ganoderma spore oil) to standard glucocorticoid therapy improves outcomes in patients with Grade 3-4 immune checkpoint inhibitor-related pneumonitis (CIP), compared with standard glucocorticoid therapy alone. A total of 60 patients with malignancies who develop Grade 3-4 CIP (per CTCAE v5.0) after at least one cycle of immune checkpoint inhibitor therapy will be randomized 1:1 to the experimental or control arm. The primary endpoints are time to pneumonitis downgrading and the proportion of patients achieving downgrading at 3 months.
Timeline
- Start
- 2026-04
- Primary completion
- 2028-12
- Completion
- 2029-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fish oil-grape seed-blueberry soft capsule | Unknown | 1200 mg | Oral |
| Subject | Ganoderma spore oil | Unknown | 800 mg | Oral |
| Subject | Spirulina-Bifidobacterium capsule | Unknown | 1080 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | — | — |