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Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP

Primary Purpose

Pneumonitis, Malignant Tumor

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Pirfenidone, methylprednisolone

Methylprednisolone

About this trial

This is an interventional treatment trial for Pneumonitis focused on measuring Pirfenidone, Methylprednisolone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Zhou ChengzhiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental group

Control group

Arm Description

Grade 3-4 checkpoint inhibitor-related pneumonitis

Outcomes

Primary Outcome Measures

Degradation time of CIP

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

The number of enrollments reduced by grade 1 in 3 months divided by the total number of enrollments.

Secondary Outcome Measures

Safety(Adverse Events)

Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTCAE 4.0)

Total amount of hormone

Total amount of methylprednisolone

MMRC score

Change of Modified Medical Research Council Dyspnea Scale

Full Information

NCT ID

NCT05280873

First Posted

October 11, 2021

Last Updated

March 6, 2022

Sponsor

Zhou Chengzhi

Collaborators

Beijing Continent Pharmaceutical Co, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05280873

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 10, 2021 (Actual)

Primary Completion Date

October 20, 2023 (Anticipated)

Study Completion Date

October 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhou Chengzhi

Collaborators

Beijing Continent Pharmaceutical Co, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonitis, Malignant Tumor

Keywords

Pirfenidone, Methylprednisolone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Grade 3-4 checkpoint inhibitor-related pneumonitis

Arm Title

Control group

Arm Type

Experimental

Arm Description

Grade 3-4 checkpoint inhibitor-related pneumonitis

Intervention Type

Drug

Intervention Name(s)

Pirfenidone, methylprednisolone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

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

Primary Outcome Measure Information:

Title

Degradation time of CIP

Description

According to CTCAE 4.0 and imaging grade of CIP, the time of reduction by one grade was evaluated.

Time Frame

Approximately 3 months

Title

Proportion of degradation within three months

Description

The number of enrollments reduced by grade 1 in 3 months divided by the total number of enrollments.

Time Frame

Approximately 3 months

Secondary Outcome Measure Information:

Title

Safety(Adverse Events)

Description

Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTCAE 4.0)

Time Frame

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

Title

Total amount of hormone

Description

Total amount of methylprednisolone

Time Frame

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

Title

MMRC score

Description

Change of Modified Medical Research Council Dyspnea Scale

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chengzhi Zhou, MD

Phone

13560351186

doctorzcz@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xinqing Lin, Doctor

Phone

13068863939

linxinqing81@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chengzhi Zhou, MA

Organizational Affiliation

The First Affiliated Hospital of Guangzhou Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Zhou Chengzhi

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chengzhi Zhou, Professor

Phone

13560351186

doctorzcz@163.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan.

Learn more about this trial

Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP

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