NCT04980716 Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 524 participants in total. It began in 2021-06-01 with a primary completion date of 2026-01-31.

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.

Eligibility 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. 15. Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.

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