Immune Checkpoint Inhibitor-Related PneumonitisNCT07554885
Nutritional + Usual Corticosteroids Randomized Trial for Immune-Related pneumoniA - Therapeutic Utilization Evaluation
A study testing Spirulina-Bifidobacterium capsule, Fish oil-grape seed-blueberry soft capsule and Ganoderma spore oil in people with Immune Checkpoint Inhibitor-Related Pneumonitis and Drug-Related Side Effects and Adverse Reactions, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune Checkpoint Inhibitor-Related Pneumonitis, Drug-Related Side Effects and Adverse Reactions, Neoplasms
- What is being tested?
- Spirulina-Bifidobacterium capsule, Fish oil-grape seed-blueberry soft capsule and Ganoderma spore oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangzhou Medical University, Department of Pulmonary Oncology
Guangzhou, Guangdong, 510120
Fei Wang, +86 18355293991, doctorlzk@163.com
Chengzhi Zhou, MD
About this study
Official title: A Single-Center, Open-Label, Randomized Controlled Clinical Trial Comparing Nutritional Therapy (Spirulina-Bifidobacterium Capsules, Fish Oil-Grape Seed-Blueberry Soft Capsules, and Ganoderma Spore Oil) Combined With Standard Glucocorticoid Regimen Versus Standard Glucocorticoid Regimen Alone in the Treatment of Immune Checkpoint Inhibitor-Related Pneumonitis
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.
Read the detailed description
BACKGROUND:
Immune checkpoint inhibitor-related pneumonitis (CIP) accounts for the largest proportion of fatal immune-related adverse events. Approximately 30% of patients respond poorly to corticosteroid therapy, and long-term high-dose steroids increase the risk of secondary infection. Oxidative stress plays a key role in pulmonary fibrosis. The investigational nutritional products have demonstrated antioxidant and immunomodulatory properties in preclinical and clinical studies.
OBJECTIVES:
Primary: To evaluate the efficacy of nutritional therapy combined with glucocorticoids versus glucocorticoids alone in treating CIP, as measured by time to pneumonitis downgrading and the 3-month downgrading rate.
Secondary: To evaluate safety (AE/SAE incidence, severity), total steroid dose and duration, and changes in 6-minute walk distance (6MWD), modified Medical Research Council dyspnea scale (mMRC), St George's Respiratory Questionnaire (SGRQ), and Leicester Cough Questionnaire (LCQ).
Exploratory: To analyze the relationship between treatment response and changes in T-cell subsets, inflammatory cytokines (IL-1 beta, IL-6, IL-10), KL-6, ALC, CD4+ Th1/Th17, Tregs, NLR, AEC, and gut microbiome.
STUDY DESIGN:
Sixty eligible participants will be randomized 1:1 to:
- Experimental arm: Spirulina-Bifidobacterium capsules 1080 mg twice daily orally, fish oil-grape seed-blueberry soft capsules 1200 mg twice daily orally, and Ganoderma spore oil 800 mg twice daily orally, plus methylprednisolone (dose and tapering per investigator assessment, referencing NCCN Guidelines 2025 v1).
- Control arm: Matching placebo orally plus methylprednisolone (per NCCN Guidelines 2025 v1), tapered until symptoms and imaging improve and then discontinued.
Pneumonitis imaging (chest X-ray or CT) will be assessed at baseline and on Days 3, 7, 14, 28, 42, and 56, and at 2-3 months post-treatment, with additional imaging as clinically indicated. Pneumonitis grade will be determined by an Independent Radiologic Review Committee (IRRC) blinded to treatment allocation.
PARTICIPANTS:
Adults 18-75 years of age with histologically or cytologically confirmed malignancy, who have received at least one cycle of immune checkpoint inhibitor therapy, and who develop Grade 3-4 CIP per CTCAE v5.0 and radiologic grading.
FOLLOW-UP:
All participants will be followed for 2 years or until death, with contacts every 90 (plus or minus 7) days.
- Conditions
- Immune Checkpoint Inhibitor-Related Pneumonitis, Drug-Related Side Effects and Adverse Reactions, Neoplasms
- Being tested
- Spirulina-Bifidobacterium capsule, Fish oil-grape seed-blueberry soft capsule, Ganoderma spore oil, Methylprednisolone, Matching placebo
- Keywords
- Immune checkpoint inhibitor, Pneumonitis, Immune-related adverse events, Glucocorticoids, Spirulina, Bifidobacterium, Grape seed proanthocyanidin, Ganoderma spore oil, Antioxidant
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Neoplasms, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina-Bifidobacterium capsuleDietary supplement
1080 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.
Fish oil-grape seed-blueberry soft capsuleDietary supplement
1200 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.
Ganoderma spore oilDietary supplement
800 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death.
Dose and tapering schedule per investigator assessment, referencing NCCN Guidelines 2025 version 1 for immune-related pneumonitis, continued until clinical and radiologic improvement and then tapered to discontinuation.
Matching placeboOther
Oral placebo capsules identical in appearance, color, shape, size, odor, taste, packaging, label, route, and dosing frequency to the investigational nutritional products, administered to maintain blinding and control for non-specific effects.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Therapy Plus Glucocorticoid | Experimental | Participants receive Spirulina-Bifidobacterium capsules 1080 mg orally twice daily, fish oil-grape seed-blueberry soft capsules 1200 mg orally twice daily, and Ganoderma spore oil 800 mg orally twice daily, in addition to methylprednisolone administered per investigator assessment (referencing NCCN Guidelines 2025 v1), until pneumonitis resolution, intolerance, or death. Receives: Dietary Supplement: Spirulina-Bifidobacterium capsule; Dietary Supplement: Fish oil-grape seed-blueberry soft capsule; Dietary Supplement: Ganoderma spore oil; Drug: Methylprednisolone |
| Placebo Plus Glucocorticoid | Placebo comparator | Participants receive matching placebo capsules (identical in appearance, color, shape, size, odor, taste, packaging, label, route, and dosing frequency to the investigational nutritional products) in addition to methylprednisolone administered per investigator assessment (referencing NCCN Guidelines 2025 v1), tapered until symptoms and imaging improve and then discontinued. Receives: Drug: Methylprednisolone; Other: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to immune-related pneumonitis downgrading
Time from randomization to the first imaging assessment, confirmed by the Independent Radiologic Review Committee, showing a reduction of at least 1 grade in pneumonitis severity compared with baseline, per CTCAE v5.0 and radiologic grading.
Measured: From randomization until first IRRC-confirmed pneumonitis grade reduction of at least 1 grade, assessed up to 6 months
Proportion of participants with pneumonitis downgrading at 3 months
Proportion of participants in each arm with an IRRC-confirmed reduction of at least 1 pneumonitis grade from baseline within 3 months after randomization.
Measured: 3 months (plus or minus 7 days) after randomization
Secondary outcomes (7)
Change from baseline in 6-minute walk distance (6MWD)
Distance (meters) walked in 6 minutes on a flat, hard surface, measured according to a standardized protocol by trained personnel.
Measured: Baseline, Day 28, Day 56, Month 2-3
Change from baseline in modified Medical Research Council (mMRC) dyspnea scale
Self-reported dyspnea severity on the 0-4 mMRC scale, where 0 indicates no dyspnea except with strenuous exercise and 4 indicates dyspnea too severe to leave the house.
Measured: Baseline, Day 28, Day 56, Month 2-3
Change from baseline in St George's Respiratory Questionnaire (SGRQ) total score
Validated Chinese version of SGRQ; total score ranges 0-100, higher scores indicate worse respiratory-related quality of life.
Measured: Baseline, Day 28, Day 56, Month 2-3
Change from baseline in Leicester Cough Questionnaire (LCQ) score
Validated Chinese version of LCQ; total score ranges 3-21, higher scores indicate better cough-related quality of life.
Measured: Baseline, Day 28, Day 56, Month 2-3
Total cumulative corticosteroid dose
Total cumulative glucocorticoid dose used for CIP, expressed in methylprednisolone-equivalent milligrams.
Measured: From randomization to end of corticosteroid treatment, up to approximately 6 months
Duration of corticosteroid treatment
Total number of days on glucocorticoid therapy for CIP, from initiation to final discontinuation.
Measured: From randomization to end of corticosteroid treatment, up to approximately 6 months
Incidence of adverse events, treatment-related adverse events, and serious adverse events
Incidence, severity (CTCAE v5.0), and relationship to study treatment of all AEs, TRAEs, and SAEs.
Measured: From randomization through 30 days after last dose; SAEs collected through 90 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint Inhibitor-Related PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants are randomized 1:1 to either the nutritional therapy plus glucocorticoid arm or the glucocorticoid-only (matching placebo) arm. Stratification factors: tumor type and CIP grade (3 vs 4).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Chengzhi Zhou, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554885
- Sponsor's protocol ID
- CROC-Edinburgh001
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding sharing of individual participant data has not yet been made. A plan will be provided before publication of study results.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Randomized Controlled Clinical Trial Comparing Nutritional Therapy (Spirulina-Bifidobacterium Capsules, Fish Oil-Grape Seed-Blueberry Soft Capsules, and Ganoderma Spore Oil) Combined With Standard Glucocorticoid Regimen Versus Standard Glucocorticoid Regimen Alone in the Treatment of Immune Checkpoint Inhibitor-Related Pneumonitis
- ClinicalTrials.gov ID
- NCT07554885
- Acronym / sponsor ID
- CROC-Edinburgh001
- Conditions
- Immune Checkpoint Inhibitor-Related Pneumonitis, Drug-Related Side Effects and Adverse Reactions, Neoplasms
- Keywords
- Immune checkpoint inhibitor, Pneumonitis, Immune-related adverse events, Glucocorticoids, Spirulina, Bifidobacterium, Grape seed proanthocyanidin, Ganoderma spore oil
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Immune checkpoint inhibitor-related pneumonitis (CIP) accounts for the largest proportion of fatal immune-related adverse events. Approximately 30% of patients respond poorly to corticosteroid therapy, and long-term high-dose steroids increase the risk of secondary infection. Oxidative stress plays a key role in pulmonary fibrosis. The investigational nutritional products have demonstrated antioxidant and immunomodulatory properties in preclinical and clinical studies.
OBJECTIVES:
Primary: To evaluate the efficacy of nutritional therapy combined with glucocorticoids versus glucocorticoids alone in treating CIP, as measured by time to pneumonitis downgrading and the 3-month downgrading rate.
Secondary: To evaluate safety (AE/SAE incidence, severity), total steroid dose and duration, and changes in 6-minute walk distance (6MWD), modified Medical Research Council dyspnea scale (mMRC), St George's Respiratory Questionnaire (SGRQ), and Leicester Cough Questionnaire (LCQ).
Exploratory: To analyze the relationship between treatment response and changes in T-cell subsets, inflammatory cytokines (IL-1 beta, IL-6, IL-10), KL-6, ALC, CD4+ Th1/Th17, Tregs, NLR, AEC, and gut microbiome.
STUDY DESIGN:
Sixty eligible participants will be randomized 1:1 to:
- Experimental arm: Spirulina-Bifidobacterium capsules 1080 mg twice daily orally, fish oil-grape seed-blueberry soft capsules 1200 mg twice daily orally, and Ganoderma spore oil 800 mg twice daily orally, plus methylprednisolone (dose and tapering per investigator assessment, referencing NCCN Guidelines 2025 v1).
- Control arm: Matching placebo orally plus methylprednisolone (per NCCN Guidelines 2025 v1), tapered until symptoms and imaging improve and then discontinued.
Pneumonitis imaging (chest X-ray or CT) will be assessed at baseline and on Days 3, 7, 14, 28, 42, and 56, and at 2-3 months post-treatment, with additional imaging as clinically indicated. Pneumonitis grade will be determined by an Independent Radiologic Review Committee (IRRC) blinded to treatment allocation.
PARTICIPANTS:
Adults 18-75 years of age with histologically or cytologically confirmed malignancy, who have received at least one cycle of immune checkpoint inhibitor therapy, and who develop Grade 3-4 CIP per CTCAE v5.0 and radiologic grading.
FOLLOW-UP:
All participants will be followed for 2 years or until death, with contacts every 90 (plus or minus 7) days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants are randomized 1:1 to either the nutritional therapy plus glucocorticoid arm or the glucocorticoid-only (matching placebo) arm. Stratification factors: tumor type and CIP grade (3 vs 4).
| Arm | Type | Receives |
|---|---|---|
| Nutritional Therapy Plus Glucocorticoid | Experimental | Dietary Supplement: Spirulina-Bifidobacterium capsule, Dietary Supplement: Fish oil-grape seed-blueberry soft capsule, Dietary Supplement: Ganoderma spore oil, Drug: MethylprednisoloneParticipants receive Spirulina-Bifidobacterium capsules 1080 mg orally twice daily, fish oil-grape seed-blueberry soft capsules 1200 mg orally twice daily, and Ganoderma spore oil 800 mg orally twice daily, in addition to methylprednisolone administered per investigator assessment (referencing NCCN Guidelines 2025 v1), until pneumonitis resolution, intolerance, or death. |
| Placebo Plus Glucocorticoid | Placebo comparator | Drug: Methylprednisolone, Other: Matching placeboParticipants receive matching placebo capsules (identical in appearance, color, shape, size, odor, taste, packaging, label, route, and dosing frequency to the investigational nutritional products) in addition to methylprednisolone administered per investigator assessment (referencing NCCN Guidelines 2025 v1), tapered until symptoms and imaging improve and then discontinued. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirulina-Bifidobacterium capsule1080 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death. | Dietary supplement | Nutritional Therapy Plus Glucocorticoid |
| Fish oil-grape seed-blueberry soft capsule1200 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death. | Dietary supplement | Nutritional Therapy Plus Glucocorticoid |
| Ganoderma spore oil800 mg orally twice daily, from randomization until pneumonitis resolution, intolerance, or death. | Dietary supplement | Nutritional Therapy Plus Glucocorticoid |
| MethylprednisoloneDose and tapering schedule per investigator assessment, referencing NCCN Guidelines 2025 version 1 for immune-related pneumonitis, continued until clinical and radiologic improvement and then tapered to discontinuation. | Drug | Nutritional Therapy Plus Glucocorticoid, Placebo Plus Glucocorticoid |
| Matching placeboOral placebo capsules identical in appearance, color, shape, size, odor, taste, packaging, label, route, and dosing frequency to the investigational nutritional products, administered to maintain blinding and control for non-specific effects. | Other | Placebo Plus Glucocorticoid |
Primary outcome
Time to immune-related pneumonitis downgrading
Time frame: From randomization until first IRRC-confirmed pneumonitis grade reduction of at least 1 grade, assessed up to 6 months
Time from randomization to the first imaging assessment, confirmed by the Independent Radiologic Review Committee, showing a reduction of at least 1 grade in pneumonitis severity compared with baseline, per CTCAE v5.0 and radiologic grading.
Proportion of participants with pneumonitis downgrading at 3 months
Time frame: 3 months (plus or minus 7 days) after randomization
Proportion of participants in each arm with an IRRC-confirmed reduction of at least 1 pneumonitis grade from baseline within 3 months after randomization.
7 secondary outcomes
Change from baseline in 6-minute walk distance (6MWD)
Time frame: Baseline, Day 28, Day 56, Month 2-3
Change from baseline in modified Medical Research Council (mMRC) dyspnea scale
Time frame: Baseline, Day 28, Day 56, Month 2-3
Change from baseline in St George's Respiratory Questionnaire (SGRQ) total score
Time frame: Baseline, Day 28, Day 56, Month 2-3
Change from baseline in Leicester Cough Questionnaire (LCQ) score
Time frame: Baseline, Day 28, Day 56, Month 2-3
Total cumulative corticosteroid dose
Time frame: From randomization to end of corticosteroid treatment, up to approximately 6 months
Duration of corticosteroid treatment
Time frame: From randomization to end of corticosteroid treatment, up to approximately 6 months
Incidence of adverse events, treatment-related adverse events, and serious adverse events
Time frame: From randomization through 30 days after last dose; SAEs collected through 90 days after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided. The decision regarding sharing of individual participant data has not yet been made. A plan will be provided before publication of study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chengzhi Zhou, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina-Bifidobacterium capsule, Fish oil-grape seed-blueberry soft capsule and Ganoderma spore oil in people with Immune Checkpoint Inhibitor-Related Pneumonitis and Drug-Related Side Effects and Adverse Reactions, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Wang (+86 18355293991, doctorlzk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to immune-related pneumonitis downgrading (time frame: From randomization until first IRRC-confirmed pneumonitis grade reduction of at least 1 grade, assessed up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.