A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Study Overview
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Brief Summary
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A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Detailed Description
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This is a perspective, self-controlled cohort study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs (PD-1 immune checkpoint blockades) on atherosclerotic carotid plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the: ① The mean intima-media thickness of the common carotid artery (Mean CCA thickness); ② The maximum intima-media thickness of the internal carotid artery (maximum ICA thickness); ③ Carotid plaque burden: by calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the above-mentioned parameters at the same location of carotid artery in each patient when initiate the first-dose of anti-PD-1 mAbs therapy and 3 months post anti-PD-1 mAbs therapy. It is designed to assess the effectiveness of anti-PD-1 mAbs on the progression of carotid plaques.

Official Title
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A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Conditions
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Plaque, Atherosclerotic, Immune Checkpoint Inhibitors, Programmed Cell Death Protein 1 Inhibitor, Carotid Artery Plaque, Intimal Medial Thickness of Internal Carotid Artery

Intervention / Treatment
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* Drug: PD-1 immune checkpoint blockades


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age of subjects are between 18-90 years old (including 18 and 90 years old); All kinds of tumor diseases of subjects are acceptable; All kinds of PD-1 immune checkpoint blockades or dosages are acceptable; The subjects knew about the experiment and signed the informed consent voluntarily; The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months; The subjects complicated with atherosclerotic carotid plaques. Exclusion Criteria: Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up; Subjects are reluctant to continue to be involved in this study; Known pregnant and lactating women; The parameters (e.g., CCA intima-media, ICA intima-media or carotid plaque burden) could not be calculated because of the quality of ultrasound image; Other situations that the researchers judged were not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PD-1 immune checkpoint blockades|intravenous injection; frequency: 2-3 weeks/cycle; duration: 3 months|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean intima-media thickness of the common carotid artery | It was measured over a segment of the common carotid artery that was 1 cm long, located approximately 0.5 cm below the carotid-artery bulb, and considered not to contain any plaque (i.e., not to have any perceivable protrusion of the artery wall into the lumen). | 3 months | 
| The maximum intima-media thickness of the internal carotid artery | It was defined as the greatest intima-media thickness in either the right or left internal carotid artery extending from the bulb to 1 cm above the carotid sinus, ascertained from a total of four views on each side. | 3 months | 
| Carotid plaque burden | Carotid plaque area measured by ultrasound (cross-sectional area of longitudinal views of all plaques seen) to quantify the increase or decrease of atherosclerotic carotid plaques. | 3 months |