Adaptive Hypofractionated Radiotherapy for Locally Advanced NSCLC Based on Dynamic Enhanced MRI

Korábbi kezelés

• Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study.
• Major surgery performed within 4 weeks prior to entering the study (excluding vascular access).
• Receipt of a live attenuated vaccine within 30 days prior to the start of the study.

Más betegség

• Histological type of mixed small cell and non-small cell lung cancer.
• History or occurrence of autoimmune disease within the past 2 years.
• Active or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• History of primary immunodeficiency.
• History of organ transplantation requiring immunosuppressive therapy.
• Uncontrolled comorbidities, including but not limited to persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active bleeding disorder, human immunodeficiency virus (HIV), or psychiatric/social situations that would limit compliance with study requirements or impair the ability to provide written informed consent.
• Active tuberculosis.
• History of another primary malignancy within 5 years, excluding adequately treated basal or squamous cell skin cancer or in situ cervical cancer.

Laborértékek

• The presence of sensitive EGFR mutations or ALK rearrangements.
• Average QT interval (QTc) ≥ 470 ms calculated from 3 ECG cycles using Bazett's correction.

Egyéb

• Contraindications to MRI examination.
• Pregnant or breastfeeding women; or males and females of reproductive potential not using effective contraception.

• Male or female aged between 18 and 75 years old.
• Patients must have histological or cytological confirmation of locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC).
• No prior radiation therapy or surgery.
• Expected life expectancy of at least 12 weeks.
• World Health Organization (WHO) performance status score of 0 or 1.
• Able to undergo magnetic resonance imaging (MRI) examination.
• Organ and bone marrow function meeting the following criteria: Forced expiratory volume in 1 second (FEV1) ≥ 800 ml; Absolute neutrophil count ≥ 1.5 × 10\^9/L; Platelets ≥ 100 × 10\^9/L; Hemoglobin ≥ 9.0 g/dL; Serum creatinine clearance rate calculated by the Cockcroft-Gault formula ≥ 50 mL/min (Cockcroft and Gault 1976); Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN.