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NCT04980716RecruitingPhase 3

Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients

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.

Source: ClinicalTrials.gov · Last updated 18 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
524 (estimated)
First submitted
24 Jul 2021
Start date
1 Jun 2021
Primary completion date
31 Jan 2026
Lead sponsor
Sun Yat-sen University
Diseases
Lung cancer
NCT number
NCT04980716

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 524
  • From 1 Jun 2021 to the primary completion date, 31 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.

Other illness

  • Unstable angina or myocardial infarction occurred in the past month;
  • Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
  • Heart failure that has not been controlled;
  • Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;
  • 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.

Lab values

  • 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;

Other

  • PS score 2-4;
  • Active endocarditis;
  • Symptomatic severe aortic stenosis;
  • Suspected or confirmed aortic dissection;
  • Uncontrolled bronchial asthma;
  • Pulmonary edema;
  • Fingertip blood oxygen saturation at rest ≤85%;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.