Status:
UNKNOWN
Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury
Lead Sponsor:
Beijing Continent Pharmaceutical Co, Ltd.
Collaborating Sponsors:
Shanghai Genomics, Inc.
GNI-EPS Pharmaceuticals, Inc. (GNI Group)
Conditions:
Radiation Pneumonitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.
Eligibility Criteria
Inclusion
- 18-70 years old (include 18 and 70 years), male or female
- The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline
- General condition assessment, ECOG score of 0-1
- Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L
- The expected survival at 6 months or more
- Subject is able to eat solid food
- The initial radical thoracic radiotherapy treatment
- The clinical diagnosis of radiation-induced lung injury in Grade 2 or above
- The duration of radiation-induced lung injury in less than 1 month
- Signed informed consent
Exclusion
- Radiation-induced lung injury has entered the chronic phase
- A history of chronic bronchitis, emphysema, or a history of cor pulmonale
- Lung resection surgery
- Cancer progression
- Pulmonary infection
- Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc.
- With active peptic ulcer
- Pregnant women and patients with mental disease
- Those who participate in clinical trials of other drugs within 3 months
- Investigator judge does not apply to participate in the trial
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02296281
Start Date
January 1 2015
Last Update
November 20 2014
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