PneumonitisPhase 1NCT05280873
Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP
A Phase 1 study testing Pirfenidone, methylprednisolone and Methylprednisolone in people with Pneumonitis and Malignant Tumor, run by Zhou Chengzhi at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pneumonitis, Malignant Tumor
- What is being tested?
- Pirfenidone, methylprednisolone and Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2021to 20 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhou Chengzhi
Guangzhou, Guangdong, 510120
Chengzhi Zhou, Professor, 13560351186, doctorzcz@163.com
About this study
Official title: Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis
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.
Read the 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.
- Conditions
- Pneumonitis, Malignant Tumor
- Being tested
- Pirfenidone, methylprednisolone, Methylprednisolone
- Keywords
- Pirfenidone, Methylprednisolone
- Medical subject headings
- Pneumonia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone, methylprednisoloneDrug
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 2 mg / kg / d . Methylprednisolone was gradually reduced after the improvement of symptoms and imaging. The treatment course was 6-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Grade 3-4 checkpoint inhibitor-related pneumonitis Receives: Drug: Pirfenidone, methylprednisolone |
| Control group | Experimental | Grade 3-4 checkpoint inhibitor-related pneumonitis Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degradation time of CIP
According to CTCAE 4.0 and imaging grade of CIP, the time of reduction by one grade was evaluated.
Measured: 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.
Measured: Approximately 3 months
Secondary outcomes (3)
Safety(Adverse Events)
Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTCAE 4.0)
Measured: From the day the patient signs informed consent form until 30 days after the last medication
Total amount of hormone
Total amount of methylprednisolone
Measured: From the day the patient signs informed consent to the last medication，assessed up to 24 months
MMRC score
Change of Modified Medical Research Council Dyspnea Scale
Measured: From the day the patient received treatment until 30 days after the last medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start10 Oct 2021
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We randomly divided the patients into two groups and received pirfenidone combined with methylprednisolone or methylprednisolone.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Continent Pharmaceutical Co, Ltd.
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Chengzhi Zhou, MA, Study director, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280873
- Sponsor's protocol ID
- CROC202107
- Status last verified
- Mar 2022
- First submitted
- 11 Oct 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis
- ClinicalTrials.gov ID
- NCT05280873
- Acronym / sponsor ID
- CROC202107
- Conditions
- Pneumonitis, Malignant Tumor
- Keywords
- Pirfenidone, Methylprednisolone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Collaborators
- Beijing Continent Pharmaceutical Co, Ltd.
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We randomly divided the patients into two groups and received pirfenidone combined with methylprednisolone or methylprednisolone.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Pirfenidone, methylprednisoloneGrade 3-4 checkpoint inhibitor-related pneumonitis |
| Control group | Experimental | Drug: MethylprednisoloneGrade 3-4 checkpoint inhibitor-related pneumonitis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirfenidone, methylprednisoloneMethylprednisolone 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 | Experimental group |
| MethylprednisoloneMethylprednisolone 2 mg / kg / d . Methylprednisolone was gradually reduced after the improvement of symptoms and imaging. The treatment course was 6-8 weeks | Drug | Control group |
Primary outcome
Degradation time of CIP
Time frame: 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
Time frame: Approximately 3 months
The number of enrollments reduced by grade 1 in 3 months divided by the total number of enrollments.
3 secondary outcomes
Safety(Adverse Events)
Time frame: From the day the patient signs informed consent form until 30 days after the last medication
Total amount of hormone
Time frame: From the day the patient signs informed consent to the last medication，assessed up to 24 months
MMRC score
Time frame: From the day the patient received treatment until 30 days after the last medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No. No plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chengzhi Zhou, MA study director
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pirfenidone, methylprednisolone and Methylprednisolone in people with Pneumonitis and Malignant Tumor, run by Zhou Chengzhi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengzhi Zhou, MD (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degradation time of CIP (time frame: Approximately 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.