Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment.

March 9, 2026 updated by: Hui Liu, Sun Yat-sen University

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Hui Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Locally advanced non-small cell lung cancer patients treated by neoadjuvant chemotherapy plus immune checkpoint inhibitors following definitive concurrent chemoradiotherapy.

Description

Inclusion Criteria:

  1. had untreated histologically or cytologically confirmed NSCLC
  2. be between the age of 18 and 75
  3. had unresectable stage IIIA-IIIC disease, as defined by the AJCC 8th edition staging system
  4. had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0~1
  5. 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)
  6. had a forced expiratory volume in 1 second (FEV1) of ≥0.8L.

Exclusion Criteria:

  1. mixed small cell and NSCLC histology
  2. life expectancy lower than 12 weeks
  3. history of another primary malignancy
  4. poorly controlled intercurrent illness
  5. female in pregnancy or breast-feeding and any situation not suitable for this study judged by researchers
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Impedance cardiography
The study conducted a 6-minute walk test (6MWT) in a hospital hallway following ATS guidelines. Patients rested for 10 minutes before the test. Impedance measurements were taken before (2 minutes), during (6 minutes), and after (3 minutes) the walk, recording cardio-dynamic parameters with impedance cardiography (ICG).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 2 year after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Hui Liu, MD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2021

Primary Completion (Actual)

September 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-10108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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