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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: severe CIP with the treatment of corticosteroids | Active Comparator | severe CIP with the treatment of corticosteroids |
|
| Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib | Experimental | severe CIP with the treatment of corticosteroids and Ruxolitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroids | Drug | Initial dosage of corticosteroids is no less than predinisone 1mg/kg/d or other corticosteroids with equal equivalence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality of severe CIP patients at 8 weeks. | 8 weeks |
| Proportion of invasive ventilator assisted respiration | Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Xu | Contact | +861069155154 | maraxu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Respiratory Medicine, Peking Union Medical College Hospita | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Corticosteroids and Ruxolitinib | Drug | 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 |
|
| 8 weeks |
| Incidence of pulmonary infection | Incidence of pulmonary infection in severe CIP patients in 8 weeks. | 8 weeks |
| Total corticosteroids usage | Total corticosteroids usage for severe CIP patients in 8 weeks. | 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. | 8 weeks. |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| C540383 | ruxolitinib |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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