Severe Checkpoint Inhibitor Pneumonitis
Conditions
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.
Interventions
DRUGCorticosteroids
Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence
DRUGCorticosteroids and Ruxolitinib
Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence, add-on oral Ruxolitinib 5mg twice a day for 2 weeks, following with Ruxolitinib
Sponsors
Peking Union Medical College Hospital
Second Affiliated Hospital of Nanchang University
The Affiliated Hospital of Inner Mongolia Medical University
Shanxi Bethune Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1. | 8 weeks | Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 8 weeks | Mortality of severe CIP patients at 8 weeks. |
| Proportion of invasive ventilator assisted respiration | 8 weeks | Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks. |
| Incidence of pulmonary infection | 8 weeks | Incidence of pulmonary infection in severe CIP patients in 8 weeks. |
| Total corticosteroids usage | 8 weeks. | Total corticosteroids usage for severe CIP patients in 8 weeks. |
| The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG | 8 weeks. | The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG for severe CIP patients in 8 weeks. |
Countries
China
Outcome results
None listed