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

• Status: Recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

1. 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;

2. Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;

3. Male or female between 18 and 75 years old;

4. Life expectancy ≥ 12 weeks;

5. The World Health Organization (WHO) PS score is 0 or 1;

6. 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;

7. A signed informed consent form is required before proceeding with any step in the research;

8. There is an abnormality in the initial cardiac output index.

Exclusion Criteria:

1. PS score 2-4;

2. 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;

3. Unstable angina or myocardial infarction occurred in the past month;

4. Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;

5. Active endocarditis;

6. Symptomatic severe aortic stenosis;

7. Heart failure that has not been controlled;

8. Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;

9. Suspected or confirmed aortic dissection;

10. Uncontrolled bronchial asthma;

11. Pulmonary edema;

12. Fingertip blood oxygen saturation at rest ≤85%;

13. Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise;

14. Mental disorders make it impossible to cooperate.