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Pifenidone is Used to Reduce Radiation Lung Injury in Lung Cancer Patients Previously Treated With Immune Checkpoint Inhibitors: A Single-arm, Open-label, Phase II Study

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Patients with advanced lung cancer who have previously received immunocheckpoint inhibitor therapy, undergone chest radiation therapy again have developed radiation induced lung injury. Pirfenidone has anti-inflammatory and anti fibrosis effects. This study is intended to evaluate the effectiveness of pirfenidone combined with radiotherapy in the prevention of radiation pneumonitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The patients joined the study voluntarily and signed an informed consent form (ICF). They had good compliance and cooperated with follow-up;

• Patients with lung cancer who had received at least 2 cycles of immunomonotherapy or combination systemic therapy (including PD-1 or PD-L1 immunocheckpoint inhibitors) within 6 months;

• Age ≥ 18 years, no gender limit;

• ECOG PS score: 0~1;

• The expected survival time ≥ 3 months;

• Use appropriate methods of contraception or surgical sterilization during treatment and for 3 years after treatment for men and women of reproductive age;

• Appropriate biochemical indicators and organ function.

Locations
Other Locations
China
Hubei Cancer Hospital
RECRUITING
Wuhan
Contact Information
Primary
Guang Han, MD,PhD
hg7913@hotmail.com
13886048178
Time Frame
Start Date: 2023-03-31
Completion Date: 2025-09-01
Participants
Target number of participants: 41
Treatments
Experimental: Pirfenidone combined with radiotherapy
Pirfenidone: synchronized with RT, 200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months~Radiotherapy: no limitation, TD≥50Gy (BED/ α/β: 10)
Sponsors
Leads: Hubei Cancer Hospital

This content was sourced from clinicaltrials.gov