About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Multiple cardiovascular drugs related to "Golden Triangle"
DrugBased on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.
Treatment groups
Trial outcomes
Primary outcomes
Overall survival
It was calculated from the first day of treatment to the day of death.
The incidence of grade 2+ cardiotoxicity events
Culmulative incidence of grade 2+ cardiotoxicity events
Secondary outcomes
Progression-free survival
From the first day of treatment to the day of progression or the day of death.
The incidence of grade 2+ pulmonary toxicity
Culmulative incidence of grade 2+ pulmonary toxicity
Sponsors and contacts
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