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Study identifier: NCT07388680 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia

Condition: Radiation-induced Lung Injury · Immune-related Pneumonia  ·  Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

PhasePhase 2/Phase 3
Planned participants298
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

Radiation-induced lung injury (RILI) is one of the most common thoracic-radiotherapy complications, with an incidence as high as 31.4 %. Multiple studies have shown that RILI can adversely affect patient prognosis by disrupting treatment schedules. Moreover, the widespread clinical use of immune-checkpoint inhibitors (ICIs) has further increased pulmonary toxicity when radiotherapy (RT) is combined with ICIs. Checkpoint-inhibitor-related pneumonitis (CIP)-i.e., immune-mediated lung injury-may necessitate permanent discontinuation of ICIs, diminish survival benefit, and, in severe cases, directly threaten life. The diagnosis of both RILI and CIP is based on an integrated assessment of subjective symptoms and imaging findings.RILI typically occurs 1-3 months after completion of radiotherapy, whereas CIP may emerge at any point during treatment. The two entities share similar clinical presentations: fever, dry cough, chest tightness, dyspnoea, and pleuritic chest pain. Computed tomography (CT) is the most sensitive imaging modality. Pulmonary-function testing is another routinely used clinical metric; vital capacity, total lung capacity, forced expiratory volume in 1 s (FEV₁), and diffusing capacity of the lung for carbon monoxide (DLCO) may all decline, with DLCO being the most sensitive parameter. In advanced cases, arterial oxygen and carbon-dioxide tensions may also deteriorate.Currently, RILI is managed empirically with systemic corticosteroids and supportive care; however,…

This description comes directly from the study's public registry record.

Talk to the study team

Ming Chen  ·  13600470913  ·  chenming@sysucc.org.cn

Always discuss trial participation with your own doctor first.

Locations (36)

Anhui Provincial Chest HospitalHefei, Anhui, ChinaRecruiting
Chinese Academy of Medical Sciences Cancer HospitalBeijing, Beijing Municipality, ChinaRecruiting
Affiliated Hospital of Fujian Medical University, Xiehe BranchFuzhou, Fujian, ChinaRecruiting
Fujian Provincial Cancer HospitalFuzhou, Fujian, ChinaRecruiting
Lanzhou University First HospitalLanzhou, Gansu, ChinaRecruiting
Foshan First HospitalFoshan, Guangdong, ChinaRecruiting
Guangdong Provincial People's HospitalGuangzhou, Guangdong, ChinaRecruiting
Panyu Central Hospital Affiliated to Guangzhou Medical UniversityGuangzhou, Guangdong, ChinaRecruiting
Southern Medical University - Southern HospitalGuangzhou, Guangdong, ChinaRecruiting
Sun Yat-sen University Cancer CenterGuangzhou, Guangdong, ChinaRecruiting
The First Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou, Guangdong, ChinaRecruiting
The First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, Guangdong, ChinaRecruiting

+ 24 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07388680