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

Zhejiang University

Status: Unknown

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

Treatments: Drug: PD-1 immune checkpoint blockades

Study type: Observational

Funder types: Other

Identifiers

NCT05123287

2019-221

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The age of subjects are between 18-90 years old (including 18 and 90 years old);
2. All kinds of tumor diseases of subjects are acceptable;
3. All kinds of PD-1 immune checkpoint blockades or dosages are acceptable;
4. The subjects knew about the experiment and signed the informed consent voluntarily;
5. The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months;
6. The subjects complicated with atherosclerotic carotid plaques.

Exclusion criteria

1. Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up;
2. Subjects are reluctant to continue to be involved in this study;
3. Known pregnant and lactating women;
4. 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;
5. Other situations that the researchers judged were not suitable for inclusion.