Nutritional Therapy Plus Corticosteroids for Immune Checkpoint Inhibitor-Related Pneumonitis (NCT07554885) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Nutritional Therapy Plus Corticosteroids for Immune Checkpoint Inhibitor-Related Pneumonitis
China60 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntary participation with full understanding of the study and signed informed consent form.
✓. Age 18 to 75 years (inclusive) on the day of informed consent signing.
✓. Histologically or cytologically confirmed malignancy.
✓. Received at least one cycle of immune checkpoint inhibitor therapy.
✓. ECOG performance status 0-2, with expected survival of more than 3 months.
✓. Adequate organ function based on laboratory results (without transfusion, apheresis, erythropoietin, or granulocyte colony-stimulating factor support within 14 days before the first dose). Women of childbearing potential must have a negative serum pregnancy test within 7 days before first dose.
Exclusion criteria
✕. Severe cardiac, cerebrovascular, renal, hematologic, or other serious systemic disease, including: NYHA Class III-IV heart failure; acute myocardial infarction or unstable angina within 6 months; severe post-stroke functional impairment (mRS greater than or equal to 3); progressive neurodegenerative disease; Child-Pugh Class B or C liver disease or acute liver failure; CKD stage 4-5 (eGFR less than 30 mL/min/1.73 m2) or requiring dialysis; absolute neutrophil count less than 1.5 x 10\^9/L, platelet count less than 50 x 10\^9/L, or Grade 3 or higher anemia (Hb less than 8 g/dL).
What they're measuring
1
Time to immune-related pneumonitis downgrading
Timeframe: From randomization until first IRRC-confirmed pneumonitis grade reduction of at least 1 grade, assessed up to 6 months
2
Proportion of participants with pneumonitis downgrading at 3 months
Timeframe: 3 months (plus or minus 7 days) after randomization