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New treatment option for Non-small Cell Lung Cancer
Official title Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients
ClinicalTrials.gov ID: NCT04980716
What this study is testing
What is Multiple cardiovascular drugs related to "Golden Triangle"?
Multiple cardiovascular drugs related to "Golden Triangle" is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- It is diagnosed as non-small cell lung cancer by pathological examination or cytological examination; it is assessed as locally advanced...
- 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;
You likely can't join if
- PS score 2-4;
- Organ function impairment: FEV1 \ 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;
See the full eligibility criteria
- 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...
- 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.
- PS score 2-4;
- Organ function impairment: FEV1 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.