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

Overview

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.

Description

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. The participants were 1:1 randomized to the intervention group and the control group. The intervention group will receive cardiovascular evaluation and intervention at multiple timepoints throughout treatment and follow-up, while the control group will be under observation unless severe cardiovascular events happen.

The evaluation and intervention timepoints include: Before neoadjuvant therapy (no intervention time point for those who do not receive neoadjuvant therapy), before the first course of radiotherapy, 3-4 weeks after the first course of radiotherapy, 2 months after the second course of radiotherapy, 8 months after the second course of radiotherapy, 14 months after the second course of radiotherapy .

Eligibility

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.