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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence
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
Department of Respiratory Medicine, Peking Union Medical College Hospita
Beijing, Beijing Municipality, China
RECRUITINGProportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.
Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.
Time frame: 8 weeks
Mortality
Mortality of severe CIP patients at 8 weeks.
Time frame: 8 weeks
Proportion of invasive ventilator assisted respiration
Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks.
Time frame: 8 weeks
Incidence of pulmonary infection
Incidence of pulmonary infection in severe CIP patients in 8 weeks.
Time frame: 8 weeks
Total corticosteroids usage
Total corticosteroids usage for severe CIP patients in 8 weeks.
Time frame: 8 weeks.
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG for severe CIP patients in 8 weeks.
Time frame: 8 weeks.
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