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

NCT04980716 | Recruiting Phase 3

• 1 other identifier: GASTO-1074
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer; Cardiovascular Complication

Keywords

Non-small Cell Lung Cancer; Cardiovascular Intervention; Impedance Cardiography; Cardiovascular Event

Outcome Measures

Primary Outcomes (2)

• Overall survival

  It was calculated from the first day of treatment to the day of death.

  2-year

• The incidence of grade 2+ cardiotoxicity events

  Culmulative incidence of grade 2+ cardiotoxicity events

  2-year

Secondary Outcomes (2)

• Progression-free survival

  2-year

• The incidence of grade 2+ pulmonary toxicity

  2-year

Study Arms (2)

The early intervention group

EXPERIMENTAL

The early intervention group: evaluation and intervention based on impedance cardiography results at multiple timepoints. Specific intervention measures include: 1. cardiovascular drug treatment: based on the increase and decrease of the "Golden Triangle" 1. ACEI, perindopril tert-butyrate 4mg qd 2. β receptor antagonist, metoprolol succinate 47.5mg qd 3. Spironolactone 20mg qd 4. Drugs to improve myocardial metabolism: trimetazidine hydrochloride 35 mg bid 5. Other therapeutic drugs include: loop diuretics, ARNI, sinus node If current selection specific inhibitors, statins, antiplatelet aggregation and nitrate drugs, etc. 2. Exercise intervention: exercise prescription based on the initial cardiopulmonary exercise test results.

Drug: Multiple cardiovascular drugs related to "Golden Triangle"

The control group

NO INTERVENTION

This group will be under observation. When cardiovascular events (including ischemic cardiomyopathy, heart failure, arrhythmia requiring treatment, pericardial disease requiring treatment, valvular disease, etc.) happen, a cardiovascular specialist assessment and intervention will be given.

Interventions

Multiple cardiovascular drugs related to "Golden Triangle" DRUG

Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.

The early intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• PS score 2-4;
• 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;
• Unstable angina or myocardial infarction occurred in the past month;
• Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
• Active endocarditis;
• Symptomatic severe aortic stenosis;
• Heart failure that has not been controlled;
• Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;
• Suspected or confirmed aortic dissection;
• Uncontrolled bronchial asthma;
• Pulmonary edema;
• Fingertip blood oxygen saturation at rest ≤85%;
• 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.
• Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hui Liu, Professor

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Qiu

CONTACT

+862087343031; qiubo@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: July 28, 2021
• Study Start: June 1, 2021
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CN (1)