Nutritional + Usual Corticosteroids Randomized Trial for Immune-Related pneumoniA - Therapeutic Utilization Evaluation

Starting soon · Not applicable · Has a placebo group

Conditions studied: Immune Checkpoint Inhibitor-Related Pneumonitis, Drug-Related Side Effects and Adverse Reactions, Neoplasms

In brief

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.

Key facts

Study ID

NCT07554885

Run by

Guangzhou Institute of Respiratory Disease

People needed

60

Starts

2026-04-01

Expected to finish

2029-10-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Grade 3-4 immune-related pneumonitis (per CTCAE v5.0 and radiologic grading).
• 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.

You may not qualify if…

• 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).
• Severe allergic constitution or contraindications to the study treatment.
• Significant psychiatric or psychological disorder, or doubts about the treatment plan.
• Investigator judgment that the patient is unsuitable for the trial (e.g., poor follow-up adherence, refusal of supportive care).
• Use of anti-tumor traditional Chinese medicine within 14 days before first dose.
• History of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• Severe acute or chronic infection.
• Known alcohol or drug abuse history.
• Pregnancy or breastfeeding.
• Use of antibiotics, probiotic food, or microecological preparations within 2 weeks before enrollment.
• Prior treatment-related lung injury: (a) targeted-therapy-related pulmonary toxicity (prior EGFR-TKI, ALK inhibitor, VEGF inhibitor, or antibody-drug conjugate causing interstitial lung disease or pneumonitis that has not fully resolved, with radiologic fibrosis or persistent functional impairment); (b) thoracic radiation-related lung injury (radiation pneumonitis or radiation fibrosis with irreversible CT findings).
• Use of another investigational drug within 28 days before first dose that, per investigator judgment, would interfere with evaluation of study treatment.
• Gastrointestinal disorder precluding oral administration.

Where it is running

• The First Affiliated Hospital of Guangzhou Medical University, Department of Pulmonary Oncology — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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