Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT04980716

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

Led by Sun Yat-sen University · Updated on 2025-11-18

524

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with non-small cell lung cancer confirmed by pathology or cytology
  • Assessed as locally advanced, unresectable stage III by imaging
  • Planned treatment includes radical radiotherapy and chemotherapy with or without immunotherapy
  • Male or female aged between 18 and 75 years
  • Life expectancy of at least 12 weeks
  • WHO performance status score of 0 or 1
  • Organ and bone marrow function meeting specified standards including FEV1 ≥1000 ml, neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90 g/L, creatinine clearance ≥50 mL/min, bilirubin ≤1.5 times upper limit of normal, and liver enzymes ≤2.5 times upper limit of normal
  • Signed informed consent prior to any study procedures
  • Presence of abnormal initial cardiac output index
Not Eligible

You will not qualify if you...

  • WHO performance status score of 2 to 4
  • Organ function impairment including FEV1 <1000 ml, neutrophils <1.5×10^9/L, platelets <100×10^9/L, hemoglobin <90 g/L, creatinine clearance <50 mL/min, bilirubin >1.5 times upper limit of normal, liver enzymes >2.5 times upper limit of normal
  • Unstable angina or myocardial infarction within the past month
  • Uncontrolled arrhythmia causing symptoms or abnormal hemodynamics
  • Active endocarditis
  • Symptomatic severe aortic stenosis
  • Uncontrolled heart failure
  • Acute pulmonary embolism, pulmonary infarction, or low thrombosis formation
  • Suspected or confirmed aortic dissection
  • Uncontrolled bronchial asthma
  • Pulmonary edema
  • Fingertip blood oxygen saturation at rest ≤85%
  • Acute non-cardiopulmonary diseases affecting or worsened by exercise such as infection, renal failure, or thyrotoxicosis
  • Mental disorders preventing cooperation
  • Patients clearly recommended for drug intervention per 2022 European Society of Cardiology Cardio-Oncology Guidelines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

B

Bo Qiu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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