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Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.
The study is a randomized, controlled, multi-site clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone | Experimental | pirfenidone + basic treatment |
|
| Controll | Other | with basic treatment and without pirfenidone treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | pirfenidone capsule made in China |
| |
| basic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| DLco% change | Compare DLco% from basement to the end of treatment | Week 4, 8,16, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| The grade change of radiation-induced lung injury | Week 4, 8,16, and 24 | |
| The score change of CT | Week 4, 8,16, and 24 | |
| Increase of effective lung volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing Municipality | 100021 | China | ||
| Zhejiang Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41207313 | Derived | Hou Z, Dong B, Yao Q, Chen H, Shao Q, Li M, Wang J, Chen K, Zhu Z, Peng F, Wei S, Hu X, Li J, Liu M, Xu B, Zheng S, Bi N, Zheng S, Xu Q, Chen B, Wu C, Li R, Chen W, Liu X, Tian Y, Li X, Guo S, Zhao L, Zhu Y, Cai L, Li Q, Li L, Zhang H, Hu C, Wang L, Li Q, Chen B, Chen M. Pirfenidone for grade 2 and grade 3 radiation-induced lung injury: a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Dec;26(12):1552-1562. doi: 10.1016/S1470-2045(25)00515-7. Epub 2025 Nov 6. |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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| Drug |
glucocorticoid and expectant treatment etc. |
|
| Week 4, 8,16, and 24 |
| The grade change of Cough, Dyspnea and Fever | Week 4, 8,16, and 24 |
| Hangzhou |
| Zhejiang |
| 310022 |
| China |