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: Terminated
• 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
• Genders Eligible for Study: All

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 8 and 24

Secondary Outcome Measures

Outcome Measure	Time Frame
The grade change of radiation-induced lung injury	Week 8 and 24
The score change of CT	Week 8 and 24
Increase of effective lung volume	Week 8 and 24
The grade change of Cough, Dyspnea and Fever	Week 8 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): June 13, 2022
• Study Completion (Actual): June 13, 2022

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): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

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; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; 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