Non-small Cell Lung CancerNCT06277388

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

An observational study of Non-small Cell Lung Cancer and Cardiac Toxicity, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer, Cardiac Toxicity
What is being tested?: Impedance cardiography
Type of treatment: Medical device
How many people: 231 participants
Where: 1 siteChina
Study dates: 5 Jun 2021to 30 Jun 2026
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Hui Liu
Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: 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.

Conditions: Non-small Cell Lung Cancer, Cardiac Toxicity
Being tested: Impedance cardiography
Keywords: Non-small Cell Lung Cancer, impedance cardiography, concurrent chemoradiotherapy
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Cardiotoxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Impedance cardiographyDevice
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).

Study groups in NCT06277388
Study group	Role	What they receive
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. Receives: Device: Impedance cardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

Stroke volume（SV）
The volume of blood ejected from the left ventricle of the heart in one contraction or heartbeat.
Measured: From enrollment to 2 year after radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 202130 Jun 2026

First posted26 Feb 2024
Study start5 Jun 2021
Primary completion30 Sep 2025
Study completion30 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 231 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06277388
Sponsor's protocol ID: GASTO-10108
Status last verified: Mar 2026
First submitted: 18 Feb 2024
Last updated: 11 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Wang H, Wei J, Zheng Q, Meng L, Xin Y, Yin X, Jiang X. Radiation-induced heart disease: a review of classification, mechanism and prevention. Int J Biol Sci. 2019 Aug 8;15(10):2128-2138. doi: 10.7150/ijbs.35460. eCollection 2019.
PubMed 31592122
Dess RT, Sun Y, Matuszak MM, Sun G, Soni PD, Bazzi L, Murthy VL, Hearn JWD, Kong FM, Kalemkerian GP, Hayman JA, Ten Haken RK, Lawrence TS, Schipper MJ, Jolly S. Cardiac Events After Radiation Therapy: Combined Analysis of Prospective Multicenter Trials for Locally Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2017 May 1;35(13):1395-1402. doi: 10.1200/JCO.2016.71.6142. Epub 2017 Mar 16.
PubMed 28301264
Atkins KM, Rawal B, Chaunzwa TL, Lamba N, Bitterman DS, Williams CL, Kozono DE, Baldini EH, Chen AB, Nguyen PL, D'Amico AV, Nohria A, Hoffmann U, Aerts HJWL, Mak RH. Cardiac Radiation Dose, Cardiac Disease, and Mortality in Patients With Lung Cancer. J Am Coll Cardiol. 2019 Jun 18;73(23):2976-2987. doi: 10.1016/j.jacc.2019.03.500.
PubMed 31196455
Wang K, Eblan MJ, Deal AM, Lipner M, Zagar TM, Wang Y, Mavroidis P, Lee CB, Jensen BC, Rosenman JG, Socinski MA, Stinchcombe TE, Marks LB. Cardiac Toxicity After Radiotherapy for Stage III Non-Small-Cell Lung Cancer: Pooled Analysis of Dose-Escalation Trials Delivering 70 to 90 Gy. J Clin Oncol. 2017 May 1;35(13):1387-1394. doi: 10.1200/JCO.2016.70.0229. Epub 2017 Jan 23.
PubMed 28113017
Lang CC, Agostoni P, Mancini DM. Prognostic significance and measurement of exercise-derived hemodynamic variables in patients with heart failure. J Card Fail. 2007 Oct;13(8):672-9. doi: 10.1016/j.cardfail.2007.05.004.
PubMed 17923361
Lang CC, Karlin P, Haythe J, Lim TK, Mancini DM. Peak cardiac power output, measured noninvasively, is a powerful predictor of outcome in chronic heart failure. Circ Heart Fail. 2009 Jan;2(1):33-8. doi: 10.1161/CIRCHEARTFAILURE.108.798611.
PubMed 19808313
Janssen-Heijnen ML, Schipper RM, Razenberg PP, Crommelin MA, Coebergh JW. Prevalence of co-morbidity in lung cancer patients and its relationship with treatment: a population-based study. Lung Cancer. 1998 Aug;21(2):105-13. doi: 10.1016/s0169-5002(98)00039-7.
PubMed 9829544

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT06277388
Acronym / sponsor ID: GASTO-10108
Conditions: Non-small Cell Lung Cancer, Cardiac Toxicity
Keywords: Non-small Cell Lung Cancer, impedance cardiography, concurrent chemoradiotherapy
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 231 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 5 Jun 2021 (actual)
Primary completion: 30 Sep 2025 (actual)
Study completion: 30 Jun 2026 (estimated)
First posted: 26 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Impedance cardiography(ICG)	–	Device: Impedance cardiographyThe ICG during 6MWT was performed before induction chemo-immunotherapy, before CCRT, and before consolidative immunotherapy for patients with locally advanced NSCLC.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Locally advanced non-small cell lung cancer patients treated by neoadjuvant chemotherapy plus immune checkpoint inhibitors following definitive concurrent chemoradiotherapy.

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Impedance cardiographyThe 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).	Device	Impedance cardiography(ICG)

Primary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
Background: PubMed 31592122Wang H, Wei J, Zheng Q, Meng L, Xin Y, Yin X, Jiang X. Radiation-induced heart disease: a review of classification, mechanism and prevention. Int J Biol Sci. 2019 Aug 8;15(10):2128-2138. doi: 10.7150/ijbs.35460. eCollection 2019.
Background: PubMed 28301264Dess RT, Sun Y, Matuszak MM, Sun G, Soni PD, Bazzi L, Murthy VL, Hearn JWD, Kong FM, Kalemkerian GP, Hayman JA, Ten Haken RK, Lawrence TS, Schipper MJ, Jolly S. Cardiac Events After Radiation Therapy: Combined Analysis of Prospective Multicenter Trials for Locally Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2017 May 1;35(13):1395-1402. doi: 10.1200/JCO.2016.71.6142. Epub 2017 Mar 16.
Background: PubMed 31196455Atkins KM, Rawal B, Chaunzwa TL, Lamba N, Bitterman DS, Williams CL, Kozono DE, Baldini EH, Chen AB, Nguyen PL, D'Amico AV, Nohria A, Hoffmann U, Aerts HJWL, Mak RH. Cardiac Radiation Dose, Cardiac Disease, and Mortality in Patients With Lung Cancer. J Am Coll Cardiol. 2019 Jun 18;73(23):2976-2987. doi: 10.1016/j.jacc.2019.03.500.
Background: PubMed 28113017Wang K, Eblan MJ, Deal AM, Lipner M, Zagar TM, Wang Y, Mavroidis P, Lee CB, Jensen BC, Rosenman JG, Socinski MA, Stinchcombe TE, Marks LB. Cardiac Toxicity After Radiotherapy for Stage III Non-Small-Cell Lung Cancer: Pooled Analysis of Dose-Escalation Trials Delivering 70 to 90 Gy. J Clin Oncol. 2017 May 1;35(13):1387-1394. doi: 10.1200/JCO.2016.70.0229. Epub 2017 Jan 23.
Background: PubMed 17923361Lang CC, Agostoni P, Mancini DM. Prognostic significance and measurement of exercise-derived hemodynamic variables in patients with heart failure. J Card Fail. 2007 Oct;13(8):672-9. doi: 10.1016/j.cardfail.2007.05.004.
Background: PubMed 19808313Lang CC, Karlin P, Haythe J, Lim TK, Mancini DM. Peak cardiac power output, measured noninvasively, is a powerful predictor of outcome in chronic heart failure. Circ Heart Fail. 2009 Jan;2(1):33-8. doi: 10.1161/CIRCHEARTFAILURE.108.798611.
Background: PubMed 9829544Janssen-Heijnen ML, Schipper RM, Razenberg PP, Crommelin MA, Coebergh JW. Prevalence of co-morbidity in lung cancer patients and its relationship with treatment: a population-based study. Lung Cancer. 1998 Aug;21(2):105-13. doi: 10.1016/s0169-5002(98)00039-7.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hui Liu, MD principal investigator

Sun Yat-sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer and Cardiac Toxicity, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke volume（SV） (time frame: From enrollment to 2 year after radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06277388, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.