Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury
  • Phase

    Phase 2
  • Study Type

  • Status

    Unknown status
  • Study Participants

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.
Study Started
Jan 31
Primary Completion
Jun 30
Last Update
Nov 20

Drug Pirfenidone

treatment group Experimental


Inclusion Criteria:

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 Criteria:

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
No Results Posted