JRCT ID: jRCTs031210327
Registered date:21/09/2021
Clinical trial of prednisolone for immune related interstitial lung disease
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | lung cancer, malignant mesothelioma |
Date of first enrollment | 20/01/2022 |
Target sample size | 22 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | CTCAE v5.0 grade 2 pneumonitis Patients will receive oral or intravenous prednisolone (1mg/kg/day) for 14 days. CTCAE v5.0 grade 3 pneumonitis Patients will receive intravenous prednisolone (2mg/kg/day) for 14 days. |
Outcome(s)
Primary Outcome | Percentage of cases in which CTCAE v5.0 pneumonitis grade on day 14 of prednisolone treatment improved by more than one levels from the time of regstration. |
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Secondary Outcome | CTCAE v5.0 pneumonitis grade at the end of prednisolone therapy. Toxicity Overall survival from the start of immune checkpoint inhibitors treatment Efficacy by CTCAE v5.0 pneumonitis grade Solubulate interleukin 2 receptor Bronchoalveolar lavage fluid |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Histologically confirmed non-small cell lung cancer or maligmamt mesothelioma. 2. Patients who developed drug induced interstitial lung disease with CTCAE v5.0 grade 2 or 3 during immune checkpoint inhibitors (ICIs) or within 3 months from the last day of ICIs administrarion. 3. Required systemic corticosteroid therapy for drug induced interstitial lung disease. 4. The age is over 20 years. 5. Patients providing the written informed consent. |
Exclude criteria | 1. Active comorbidity that has required continuous systemic corticosteroid or other immunosupressive agents 2. Patients with severe respiratory complication or received home oxygen therapy. 3. Patients with active infection. 4. Psychological disorder difficult to participate in this clinical study. 5. Uncontroled diabetes melitus 6. Female patients with pregnant. 7. Patients who recieve desmopressin. 8. Other immune related adverse events that has required systemic steroid therapy. |
Related Information
Primary Sponsor | Nobuyuki Hizawa |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Shiozawa Toshihiro |
Address | 1-1-1 Tennodai, Tsukuba, Ibaraki Ibaraki Japan 305-8575 |
Telephone | +81-29-853-3144 |
t-shiozawa@md.tsukuba.ac.jp | |
Affiliation | Faculty of Medicine, University of Tsukuba |
Scientific contact | |
Name | Hizawa Nobuyuki |
Address | 2-1-1 Amakubo, Tsukuba, Ibaraki Ibaraki Japan 305-8576 |
Telephone | +81-29-853-3144 |
nhizawa@md.tsukuba.ac.jp | |
Affiliation | University of Tsukuba Hospital |