The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of C… (NCT05899725) | Clinical Trial Compass
UnknownNot Applicable
The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of Checkpoint Inhibitor Pneumonia
China60 participantsStarted 2023-04-14
Plain-language summary
This study is a prospective multicenter randomized controlled Interventional study, to assess the clinical efficacy and safety of corticosteroids compared to corticosteroids in combination with Ruxolitinib in the treatment of severe checkpoint inhibitor pneumonitis.
Who can participate
Age range15 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 years old≤ Aged ≤80 years old.
✓. Diagnosis of malignancy.
✓. Malignant tumors initially treated with immune checkpoint inhibitors (antibodies targeting PD-1, PD-L1, CTLA-4, or new immune checkpoint inhibitors) in combination with or without chemotherapy.
✓. Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or 4.
✓. Patients who and whose family members understand the study protocol, are willing to participate in the study and could provide written informed consent.
Exclusion criteria
✕. Predicted life expectancy\<12 weeks.
✕. Any evidence of active or uncontrolled viral infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV), or any clinical signs of bacterial, other viral, parasitic or fungal infection requiring treatment.
✕. malignancy progression.
✕. Patients with other serious complications that may affect safety or adherence judged by the investigator.
✕. Any significant clinical and laboratory abnormalities judged by investigator that affect the safety evaluation.
✕. Patients can't fully understand the study protocol, arrangement and other study-related elements.
✕. Patients with evidence of severe liver or kidney dysfunction judged by investigator unsuitable for enrolment.
What they're measuring
1
Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.