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

Официальное название

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.

Обзор

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.

Подробное описание

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, before radiotherapy, Mid-radiotherapy, 2 months after the completion of radiotherapy, every 6 months thereafter for up to 2 years post-radiotherapy.

Вмешательства

• Препарат Multiple cardiovascular drugs related to "Golden Triangle"
  Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.

Первичные конечные точки

• Overall survival [Срок оценки: 2-year]
• The incidence of grade 2+ cardiotoxicity events [Срок оценки: 2-year]

Вторичные конечные точки (2)

• Progression-free survival [Срок оценки: 2-year]
• The incidence of grade 2+ pulmonary toxicity [Срок оценки: 2-year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun yat-sen University Cancer Center — Гуанчжоу

Публикации

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Идентификаторы

NCT: NCT04980716 · GASTO-1074

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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