Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP

Phase 1

Recruiting

• Conditions: Malignant Tumor; Pneumonitis
• Interventions: Drug: Methylprednisolone; Drug: Pirfenidone, methylprednisolone

• Registration Number: NCT05280873
• Lead Sponsor: Zhou Chengzhi

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.

Study Timeline

• Study Start: 2021-10-10
• Study First Submitted: 2021-10-11
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-06
• Last Update Submitted: 2022-03-06
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-15
• Primary Completion: 2023-10-20
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Methylprednisolone	Grade 3-4 checkpoint inhibitor-related pneumonitis
Experimental group	Pirfenidone, methylprednisolone	Grade 3-4 checkpoint inhibitor-related pneumonitis

Primary Outcome Measures

Name	Time	Method
Degradation time of CIP	Approximately 3 months	According to CTCAE 4.0 and imaging grade of CIP, the time of reduction by one grade was evaluated.
Proportion of degradation within three months	Approximately 3 months	The number of enrollments reduced by grade 1 in 3 months divided by the total number of enrollments.

Secondary Outcome Measures

Name	Time	Method
Safety(Adverse Events)	From the day the patient signs informed consent form until 30 days after the last medication	Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTCAE 4.0)
MMRC score	From the day the patient received treatment until 30 days after the last medication	Change of Modified Medical Research Council Dyspnea Scale
Total amount of hormone	From the day the patient signs informed consent to the last medication，assessed up to 24 months	Total amount of methylprednisolone

Trial Locations

Locations (1)

Zhou Chengzhi; 🇨🇳 Guangzhou, Guangdong, China