Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP

Malignant Tumor Clinical Trial

Official title:

Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280873
• Other study ID #: CROC202107
• Status: Recruiting
• Phase: Phase 1
• Start date: October 10, 2021
• Est. completion date: October 20, 2024

Study information

• Verified date: March 2022
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Chengzhi Zhou, MD
• Phone: 13560351186
• Email: doctorzcz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 20, 2024
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms
• Pneumonia
• Pneumonitis

Intervention

Drug:
• Pirfenidone, methylprednisolone
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
Methylprednisolone 2 mg / kg / d . Methylprednisolone was gradually reduced after the improvement of symptoms and imaging. The treatment course was 6-8 weeks

Locations

Country	Name	City	State
China	Zhou Chengzhi	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhou Chengzhi	Beijing Continent Pharmaceutical Co, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Total amount of hormone	Total amount of methylprednisolone	From the day the patient signs informed consent to the last medication,assessed up to 24 months
Secondary	MMRC score	Change of Modified Medical Research Council Dyspnea Scale	From the day the patient received treatment until 30 days after the last medication