Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients Who Receiving Radical Concurrent Chemoradiotherapy and Immunotherapy: a Prospective, Randomized Controlled, Multicenter Phase III Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
The early intervention group
The early intervention group: evaluation and intervention based on impedance cardiography results at multiple timepoints. Specific intervention measures include:
-
cardiovascular drug treatment: based on the increase and decrease of the "Golden Triangle"
-
ACEI, perindopril tert-butyrate 4mg qd
-
β receptor antagonist, metoprolol succinate 47.5mg qd
-
Spironolactone 20mg qd
-
Drugs to improve myocardial metabolism: trimetazidine hydrochloride 35 mg bid
-
Other therapeutic drugs include: loop diuretics, ARNI, sinus node If current selection specific inhibitors, statins, antiplatelet aggregation and nitrate drugs, etc.
-
Exercise intervention: exercise prescription based on the initial cardiopulmonary exercise test results.
干预措施: Multiple cardiovascular drugs related to "Golden Triangle" (Drug)
结局指标
主要结局
Overall survival
时间窗: 2-year
It was calculated from the first day of treatment to the day of death.
The incidence of grade 2+ cardiotoxicity events
时间窗: 2-year
Culmulative incidence of grade 2+ cardiotoxicity events
次要结局
- Progression-free survival(2-year)
- The incidence of grade 2+ pulmonary toxicity(2-year)
研究者
Hui Liu
Professor
Sun Yat-sen University