Clinical trial NCT05280873: Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP
Official title: Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pneumonitis
Malignant Tumor
Keywords: Pirfenidone
Methylprednisolone
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Beijing Continent Pharmaceutical Co, Ltd.
First posted: 2022-03-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We randomly divided the patients into two groups and received pirfenidone combined with methylprednisolone or methylprednisolone.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female who is 18 to 75 years old.
2. Malignant tumors proved by pathology.
3. The subject has received at least one course of immune checkpoint inhibitor treatment.
4. The subject developed grade 3-4 CIP.
5. Take proper contraceptive measures.
6. Appropriate organ system function.
7. Subjects voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

1. Previous treatment with pirfenidone.
2. Clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis greater than 50ml per day); Or significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + or above, or macrovasculitis.
3. Arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accident, deep venous thrombosis and pulmonary embolism.
4. Abdominal surgery was performed 4 weeks before enrollment, or there was a history of hollow organ perforation.
5. Use nintedanib, cyclophosphamide or cyclosporin within 56 days before enrollment.
6. Suffering from active pulmonary tuberculosis.
7. Patients with mental illness and poor compliance.
8. Sperm / egg donors within 6 months.
9. Lactating women.
10. Persons allergic to pirfenidone.
11. In the investigator's judgment, there are other factors that may have led to the termination of the study.

Primary outcomes:
measure: Degradation time of CIP
timeFrame: Approximately 3 months
measure: Proportion of degradation within three months
timeFrame: Approximately 3 months
Secondary outcomes:
measure: Safety(Adverse Events)
timeFrame: From the day the patient signs informed consent form until 30 days after the last medication
measure: Total amount of hormone
timeFrame: From the day the patient signs informed consent to the last medication，assessed up to 24 months
measure: MMRC score
timeFrame: From the day the patient received treatment until 30 days after the last medication
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhou Chengzhi
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Chengzhi Zhou, MA
role: STUDY_DIRECTOR
References: