Status:
UNKNOWN
Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP
Lead Sponsor:
Zhou Chengzhi
Collaborating Sponsors:
Beijing Continent Pharmaceutical Co, Ltd.
Conditions:
Pneumonitis
Malignant Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 ...
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 inhib...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05280873
Start Date
October 10 2021
End Date
October 20 2024
Last Update
March 15 2022
Active Locations (1)
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1
Zhou Chengzhi
Guangzhou, Guangdong, China, 510120