Hemodynamic Changes and Prognostic Analysis of Patients With Locally Advanced Non-small Cell Lung Cancer During Combined Chemoradiotherapy and Immunotherapy: An Observational Study Based on Dynamic Cardiac Output.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Stroke volume（SV）
研究概览
简要总结
This study aimed to investigate the role of impedance cardiography (ICG) in evaluating hemodynamic changes during the 6-minute walk test (6MWT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who underwent combined concurrent chemoradiotherapy (CCRT) and immunotherapy. Additionally, It sought to analyze the predictive significance of cardiac parameters to both treatment toxicity and survival prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •had untreated histologically or cytologically confirmed NSCLC
- •be between the age of 18 and 75
- •had unresectable stage IIIA-IIIC disease, as defined by the AJCC 8th edition staging system
- •had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0~1
- •had adequate bone marrow function (neutrophil count ≥1.5x109/L, hemoglobin concentration ≥90 g/L, platelet ≥100x109/L), kidney function (serum creatinine clearance ≥50 ml/min) and liver function (serum bilirubin ≤1.5 times upper limit of normal (ULN), aspartate transaminase (AST) and alanine transferase (ALT) ≤2.5 ULN)
- •had a forced expiratory volume in 1 second (FEV1) of ≥0.8L.
排除标准
- •mixed small cell and NSCLC histology
- •life expectancy lower than 12 weeks
- •history of another primary malignancy
- •poorly controlled intercurrent illness
- •female in pregnancy or breast-feeding and any situation not suitable for this study judged by researchers
- •patients with contraindications to 6MWT, including unstable angina pectoris or myocardial infarction within the past month, systolic blood pressure (SBP) over 180mmHg, diastolic blood pressure (DBP) over 100mmHg, muscle strength below grade 3, and severe spasm.
研究组 & 干预措施
Impedance cardiography(ICG)
The ICG during 6MWT was performed before induction chemo-immunotherapy, before CCRT, and before consolidative immunotherapy for patients with locally advanced NSCLC.
干预措施: Impedance cardiography (Device)
结局指标
主要结局
Stroke volume（SV）
时间窗: From enrollment to 2 year after radiotherapy
The volume of blood ejected from the left ventricle of the heart in one contraction or heartbeat.
次要结局
未报告次要终点
研究者
Hui Liu
Clinical Professor
Sun Yat-sen University