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Not Yet Recruiting
NCT07742800
Multi-Omics Prediction of Radiation Lung Injury in Immunotherapy-Treated Lung Cancer Patients
Conditions: Lung Cancer (NSCLC), Lung Cancer (SCLC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 160
Sponsor: HAN GUANG
Location: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Summary
This prospective study aims to develop a multi-omics-based predictive model for radiation pneumonitis in lung cancer patients receiving sequential immunotherapy and thoracic radiotherapy.
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 or older years with a life expectancy of at least 6 months. Additional inclusion criteria were a Zubrod performance status of 0-1, documentation of baseline chest computed tomography (CT) scans prior to the initiation of immunotherapy, receipt of at least 2 cycles of systemic therapy (PD-1) as either monotherapy or combination therapy within the past six months, voluntary participation with written informed consent, and appropriate baseline biochemical tests. The radiation dose for thoracic radiotherapy was ≥30Gy for all eligible patients in this study. No use of antibiotics within 1 week prior to the initiation of thoracic radiotherapy.
Exclusion Criteria:Participation in other interventional clinical studies or treatments, having received investigational drugs or treatments within 4 weeks prior to the first dose, or prior receipt of a solid organ or hematopoietic stem cell transplant, having an active infection, or pre-existing/active ICI-induced pneumonitis.
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Source: ClinicalTrials.gov (NCT07742800). StuddyBuddy aggregates publicly available trial information.