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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multiple cardiovascular drugs related to "Golden Triangle"

    Drug

    Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.

Treatment groups

524 Participants
are divided into 2 treatment groups
Group A: The early intervention groupExperimental treatment 1 intervention
Group B: The control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Overall survival

It was calculated from the first day of treatment to the day of death.

Time frame
2-year
2

The incidence of grade 2+ cardiotoxicity events

Culmulative incidence of grade 2+ cardiotoxicity events

Time frame
2-year

Secondary outcomes

1

Progression-free survival

From the first day of treatment to the day of progression or the day of death.

Time frame
2-year
2

The incidence of grade 2+ pulmonary toxicity

Culmulative incidence of grade 2+ pulmonary toxicity

Time frame
2-year

Other outcomes

Sponsors and contacts

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