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Recruiting NCT05899725

The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of Checkpoint Inhibitor Pneumonia

Trial Parameters

Condition Severe Checkpoint Inhibitor Pneumonitis
Sponsor Peking Union Medical College Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 15 Years
Max Age 80 Years
Start Date 2023-04-14
Completion 2025-03-01
Interventions
CorticosteroidsCorticosteroids and Ruxolitinib

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. 18 years old≤ Aged ≤80 years old. 2. Diagnosis of malignancy. 3. 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. 4. Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or 4. 5. 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: 1. Predicted life expectancy\<12 weeks. 2. 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. 3. malignancy progression. 4. Patients with other serious complications that may affect safety or adherence judged by the investigator. 5. Any significant clinical and laboratory abnormalities judge

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