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.
Overview
- Phase
- N/A
- Intervention
- Impedance cardiography
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 231
- Locations
- 1
- Primary Endpoint
- Stroke volume（SV）
- Status
- Active, Not Recruiting
- Last Updated
- last month
Overview
Brief Summary
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.
Investigators
Hui Liu
Clinical Professor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Impedance cardiography
Outcomes
Primary Outcomes
Stroke volume（SV）
Time Frame: From enrollment to 2 year after radiotherapy
The volume of blood ejected from the left ventricle of the heart in one contraction or heartbeat.