Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP

NCT05280873 | Unknown Phase 1

• 1 other identifier: CROC202107
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonitis; Malignant Tumor

Keywords

Pirfenidone; Methylprednisolone

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Safety(Adverse Events)

  From the day the patient signs informed consent form until 30 days after the last medication

• Total amount of hormone

  From the day the patient signs informed consent to the last medication，assessed up to 24 months

• MMRC score

  From the day the patient received treatment until 30 days after the last medication

Study Arms (2)

Experimental group

EXPERIMENTAL

Grade 3-4 checkpoint inhibitor-related pneumonitis

Drug: Pirfenidone, methylprednisolone

Control group

EXPERIMENTAL

Grade 3-4 checkpoint inhibitor-related pneumonitis

Drug: Methylprednisolone

Interventions

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.

Experimental group

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

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous treatment with pirfenidone.
• 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.
• Arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accident, deep venous thrombosis and pulmonary embolism.
• Abdominal surgery was performed 4 weeks before enrollment, or there was a history of hollow organ perforation.
• Use nintedanib, cyclophosphamide or cyclosporin within 56 days before enrollment.
• Suffering from active pulmonary tuberculosis.
• Patients with mental illness and poor compliance.
• Sperm / egg donors within 6 months.
• Lactating women.
• Persons allergic to pirfenidone.
• In the investigator's judgment, there are other factors that may have led to the termination of the study.

Sponsors & Collaborators

• Zhou Chengzhi: lead
• Beijing Continent Pharmaceutical Co, Ltd.: collaborator

Study Sites (1)

Zhou Chengzhi

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Pneumonia; Neoplasms

Interventions

pirfenidone; Methylprednisolone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chengzhi Zhou, MA

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Chengzhi Zhou, MD

CONTACT

13560351186; doctorzcz@163.com

Xinqing Lin, Doctor

CONTACT

13068863939; linxinqing81@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: We randomly divided the patients into two groups and received pirfenidone combined with methylprednisolone or methylprednisolone.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: March 15, 2022
• Study Start: October 10, 2021
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2024
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)