Overview

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

Status:
Recruiting
Trial end date:
2025-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking Union Medical College Hospital
Criteria
Inclusion Criteria:

1. 18 years old≤ Aged ≤75 years old.

2. Diagnosis of malignancy.

3. Malignant tumors initially treated with anti-PD-1 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 judged by investigator that
affect the safety evaluation.

6. Patients can't fully understand the study protocol, arrangement and other
study-related elements.

7. Patients with evidence of severe liver or kidney dysfunction judged by investigator
unsuitable for enrolment.

8. Women who are pregnant, breast feeding or unable to use effective contraception during
the study period and for 3 months after the completion.

9. Patients who cannot comply with study treatment and follow-up according to the trial
protocol.