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| Name | Class |
|---|---|
| Beijing Continent Pharmaceutical Co, Ltd. | INDUSTRY |
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Checkpoint inhibitor-related pneumonitis (CIP)is a common fatal immune-related adverse event of PD-1/PD-L1 inhibitors. Some CIP patients have poor effect on hormone therapy, and the remission time of CIP varies greatly. Antifibrotic drugs may be effective in patients with CIP.
Pirfenidone can inhibit the occurrence and development of pulmonary fibrosis, reduce pulmonary exudation by inhibiting VEGF and promote pulmonary recovery. In our study, subjects with checkpoint inhibitor-related pneumonitis receive pirfenidone plus methylprednisolone or methylprednisolone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Grade 3-4 checkpoint inhibitor-related pneumonitis |
|
| Control group | Experimental | Grade 3-4 checkpoint inhibitor-related pneumonitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone, methylprednisolone | Drug | Methylprednisolone 2 mg / kg / d+ pirfenidone (starting from 200mg tid, increasing to 600mg tid within one week and maintaining) . Methylprednisolone was reduced according to the researcher's evaluation of the patient's condition and the specific course of treatment was determined. |
| Measure | Description | Time Frame |
|---|---|---|
| Degradation time of CIP | According to CTCAE 4.0 and imaging grade of CIP, the time of reduction by one grade was evaluated. | Approximately 3 months |
| Proportion of degradation within three months | The number of enrollments reduced by grade 1 in 3 months divided by the total number of enrollments. | Approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety(Adverse Events) | Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTCAE 4.0) | From the day the patient signs informed consent form until 30 days after the last medication |
| Total amount of hormone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengzhi Zhou, MD | Contact | 13560351186 | doctorzcz@163.com | |
| Xinqing Lin, Doctor | Contact | 13068863939 | linxinqing81@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chengzhi Zhou, MA | The First Affiliated Hospital of Guangzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhou Chengzhi | Recruiting | Guangzhou | Guangdong | 510120 | China |
No plan.
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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We randomly divided the patients into two groups and received pirfenidone combined with methylprednisolone or methylprednisolone.
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| Methylprednisolone | Drug | Methylprednisolone 2 mg / kg / d . Methylprednisolone was gradually reduced after the improvement of symptoms and imaging. The treatment course was 6-8 weeks |
|
Total amount of methylprednisolone
| From the day the patient signs informed consent to the last medication,assessed up to 24 months |
| MMRC score | Change of Modified Medical Research Council Dyspnea Scale | From the day the patient received treatment until 30 days after the last medication |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |