Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients

This is a prospective, randomized, controlled, multi-center phase III clinical trial that intends to evaluate the role of early cardiovascular intervention based on impedance cardiography in patients with locally advanced non-small cell lung cancer receiving radical radiochemotherapy±immunotherapy. The participants were 1:1 randomized to the intervention group and the control group. The intervention group will receive cardiovascular evaluation and intervention at multiple timepoints throughout treatment and follow-up, while the control group will be under observation unless severe cardiovascular events happen.

The evaluation and intervention timepoints include: Before neoadjuvant therapy, before radiotherapy, Mid-radiotherapy, 2 months after the completion of radiotherapy, every 6 months thereafter for up to 2 years post-radiotherapy.

Inclusion criteria

• It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced, unresectable stage III non-small cell lung cancer by imaging;
• Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;
• Male or female between 18 and 75 years old;
• Life expectancy ≥ 12 weeks;
• The World Health Organization (WHO) PS score is 0 or 1;
• Organ and bone marrow function meet the following conditions: Forced expiratory volume per second (FEV1) ≥1000 ml; absolute neutrophil count ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥90 g/L ; Serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 times ULN;
• A signed informed consent form is required before proceeding with any step in the research;
• There is an abnormality in the initial cardiac output index.

Exclusion criteria

• PS score 2-4;
• Organ function impairment: FEV1 <1000ml; absolute neutrophil count <1.5×10^9/L; platelets <100×10^9/L; hemoglobin <90 g/ L; Serum creatinine clearance calculated according to Cockcroft-Gault formula <50 mL/min; serum bilirubin>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase>2.5 times ULN;
• Unstable angina or myocardial infarction occurred in the past month;
• Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
• Active endocarditis;
• Symptomatic severe aortic stenosis;
• Heart failure that has not been controlled;
• Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;
• Suspected or confirmed aortic dissection;
• Uncontrolled bronchial asthma;
• Pulmonary edema;
• Fingertip blood oxygen saturation at rest ≤85%;
• Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise;
• Mental disorders make it impossible to cooperate.
• Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.