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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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.
Methylprednisolone 2 mg / kg / d . Methylprednisolone was gradually reduced after the improvement of symptoms and imaging. The treatment course was 6-8 weeks
Zhou Chengzhi
Guangzhou, Guangdong, China
RECRUITINGDegradation time of CIP
According to CTCAE 4.0 and imaging grade of CIP, the time of reduction by one grade was evaluated.
Time frame: 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.
Time frame: Approximately 3 months
Safety(Adverse Events)
Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTCAE 4.0)
Time frame: From the day the patient signs informed consent form until 30 days after the last medication
Total amount of hormone
Total amount of methylprednisolone
Time frame: 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
Time frame: From the day the patient received treatment until 30 days after the last medication
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