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Trial Title:
Pifenidone Prophylactic Therapy for Radiation Lung Injury in Patients Who Have Previously Received Immune Checkpoint Inhibitors
NCT ID:
NCT05801133
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Lung Injury
Pirfenidone
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pirfenidone
Description:
200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of
400 mg TID from the third week until 3 months
Arm group label:
Pirfenidone combined with radiotherapy
Other name:
PFD
Other name:
AiSiRui
Summary:
Patients with advanced lung cancer who have previously received immunocheckpoint
inhibitor therapy, undergone chest radiation therapy again have developed radiation
induced lung injury. Pirfenidone has anti-inflammatory and anti fibrosis effects. This
study is intended to evaluate the effectiveness of pirfenidone combined with radiotherapy
in the prevention of radiation pneumonitis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patients joined the study voluntarily and signed an informed consent form (ICF).
They had good compliance and cooperated with follow-up;
2. Patients with lung cancer who had received at least 2 cycles of immunomonotherapy or
combination systemic therapy (including PD-1 or PD-L1 immunocheckpoint inhibitors)
within 6 months;
3. Age ≥ 18 years, no gender limit;
4. ECOG PS score: 0～1;
5. The expected survival time ≥ 3 months;
6. Use appropriate methods of contraception or surgical sterilization during treatment
and for 3 years after treatment for men and women of reproductive age；
7. Appropriate biochemical indicators and organ function.
Exclusion Criteria:
1. Currently participating in interventional clinical research and treatment, or
receiving other research drugs or treatment with research equipment within 4 weeks
before the first administration;
2. Accept solid organ or blood system transplantation;
3. Suffer from active autoimmune diseases that require hormone or immunomodulatory
treatment, such as rheumatoid arthritis, ankylosing spondylitis, type I diabetes,
psoriasis, vitiligo, immune-related thyroid dysfunction, etc. (hormone replacement
Can be included after treatment is normal);
4. Suffer from acute or chronic infectious diseases, such as hepatitis B, hepatitis C,
tuberculosis, and HIV;
5. Allergic to research drug ingredients;
6. Active infection or fever of unknown cause occurred during the screening period and
before the first administration> 38.5℃ (according to the judgment of the
investigator, the subject can be included in the group due to fever caused by the
tumor);
7. Suffer from uncontrolled clinical symptoms or diseases of the heart, such as:(1)
Heart failure above NYHA II; (2) Unstable angina pectoris; (3) Myocardial infarction
occurred within 1 year; (4) Patients with clinically significant supraventricular or
ventricular arrhythmia requiring clinical intervention;
8. Suffer from high blood pressure and cannot be well controlled by antihypertensive
medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100
mmHg);
9. Abnormal blood coagulation function (INR>2.0, PT>16s), have a bleeding tendency or
are receiving thrombolytic therapy, and allow preventive use of low-dose aspirin and
low-molecular-weight heparin;
10. Obvious coughing up blood or hemoptysis of 10ml or more per day in the 2 months
before enrollment;
11. Have significant clinically significant bleeding symptoms or have a clear bleeding
tendency within 3 months before enrollment;
12. Have received anti-tumor monoclonal antibodies (mAb) within 4 weeks before using the
study drug for the first time, or the adverse events caused by the previously
received drug have not recovered (ie ≤ grade 1 or reached the baseline level). Note:
Except for subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 hair loss, if the subject
has undergone major surgery, the toxic reaction and/or complications caused by the
surgical intervention must be fully recovered before starting treatment;
13. The investigator judged other situations not suitable for inclusion in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Guang Han, MD.Phd
Investigator:
Last name:
Guang Han, MD.Phd
Email:
Principal Investigator
Start date:
March 31, 2023
Completion date:
September 1, 2025
Lead sponsor:
Agency:
Hubei Cancer Hospital
Agency class:
Other
Source:
Hubei Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05801133
