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Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP

NCT05280873 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-03-15

No results posted yet for this study

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

Interventions

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.

DRUG

Methylprednisolone

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

Sponsors & Collaborators

  • Beijing Continent Pharmaceutical Co, Ltd.

    collaborator INDUSTRY

  • Zhou Chengzhi

    lead OTHER

Principal Investigators

  • Chengzhi Zhou, MA · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-10
Primary Completion
2023-10-20
Completion
2024-10-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05280873 on ClinicalTrials.gov