A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.

Study Overview

• Status: Completed
• Conditions: Radiation-induced Lung Injury
• Intervention / Treatment: Drug: Pirfenidone; Drug: basic treatment

Detailed Description

The study is a randomized, controlled, multi-site clinical trial.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Science
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-75 years old (including 18 and 75 years);
2. clinically diagnosed grade 2 or 3 radiation-induced lung injury;
3. the course of radiation-induced lung injury is less than 2 months;
4. ECOG 0-2;
5. the expected survival time is more than 6 months;
6. the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN
7. capable of eating solid food upon enrollment;
8. subjects will voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

1. have a history of chronic bronchial acute attack or severe pulmonary heart disease;
2. pneumonectomy;
3. tumor progression;
4. severe pulmonary infection;
5. creatinine clearance rate < 30ml/min, severe renal disease or need dialysis;
6. concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
7. patients with active peptic ulcer;
8. pregnant women and patients with mental illness;
9. participating in clinical trials of other drugs within 3 months;
10. the investigator determined that subject was not suitable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pirfenidone; pirfenidone + basic treatment	Drug: Pirfenidone; pirfenidone capsule made in China; Drug: basic treatment; glucocorticoid and expectant treatment etc.
Other: Controll; with basic treatment and without pirfenidone treatment	Drug: basic treatment; glucocorticoid and expectant treatment etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLco% change	Compare DLco% from basement to the end of treatment	Week 4, 8,16, and 24

Secondary Outcome Measures

Outcome Measure	Time Frame
The grade change of radiation-induced lung injury	Week 4, 8,16, and 24
The score change of CT	Week 4, 8,16, and 24
Increase of effective lung volume	Week 4, 8,16, and 24
The grade change of Cough, Dyspnea and Fever	Week 4, 8,16, and 24

Collaborators and Investigators

• Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2019
• Primary Completion (Actual): December 4, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: pirfenidone
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Lung Injury; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Pirfenidone
• Other Study ID Numbers: RP-F647-201901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No