Single-center, Prospective Cohort Study of PD-1 Inhibitors on Clinical Outcomes of Carotid Plaques in Tumor Patients

Zhejiang University

Status: Enrolling

Conditions: Pd-1 Inhibitors; Carotid Artery Plaque

Treatments: Drug: PD-1 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT05549336

2022-0803

Details and patient eligibility

About

This is a single-center, prospective cohort study on the comparison of clinical outcomes of carotid plaques in PD-1-treated tumor patients vs non-PD-1-treated tumor patients.

Full description

Atherosclerosis, a chronic inflammatory disorder, leads to cardio-cerebrovascular diseases, causing most of the global deaths. The chronic and non-resolved inflammatory responses of both innate and adaptive immune cells are involved in the all-stage pathogenesis of atherosclerosis. The impairment of inflammatory resolution promotes atherogenesis and causes instability of atherosclerotic plaques. Their subsequent rupture would induce severe cardio-cerebrovascular incidences (e.g., acute myocardial infarction and ischemic strokes). Recent progress in anti-inflammatory immunotherapies on human atherosclerosis opens the door to resolving this inflammatory disorder by targeting the immune system. However, the impacts of PD-1 immune checkpoint blockades on the progressions of human carotid plaques are not determined yet.

This is a prospective cohort study, which aims to evaluate the effectiveness of PD-1 immune checkpoint blockades on atherosclerotic carotid plaques in tumor patients in comparison to those with non-PD-1-treated tumor patients. The method for quantification and evaluation of atherosclerotic plaques are based on: (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 areas: 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 the carotid artery in the patients when initiating the first dose of anti-PD-1 or non-PD-1 chemotherapy and 3 months after anti-PD-1 or non-PD-1 chemotherapy. It is designed to assess the effectiveness of PD-1 immune checkpoint blockades or non-PD-1 chemotherapy on the clinical prognosis of carotid plaques after a period of 3-month treatment.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects know about the experiment and signed the informed consent voluntarily; and
2. Subjects are tumor patients and all kinds of tumor diseases of subjects are acceptable; and
3. Subjects are initiating to receive chemotherapy; and
4. Subjects are diagnosed with atherosclerotic carotid plaques by ultrasound examination at the timepoint of the first-dose treatment; and

Exclusion criteria

1. Subjects stop receiving or changing the existing chemotherapy during follow-up; or

2. Subjects are reluctant to continue to be involved in this study; or

3. Subjects are known pregnant and lactating women; or

4. Subjects are not complicated with atherosclerotic carotid plaques at the timepoint of the first-dose treatment; or

5. The parameters (e.g., CCA intima-media, ICA intima-media, or carotid plaque area) could not be calculated because of the quality of the ultrasound image; or 5. Other situations that the researchers judged are not suitable for further inclusion.

Trial design

100 participants in 2 patient groups

PD-1-treated tumor patients

Description:

Tumor patients who are initiating receive chemotherapy that includes PD-1 inhibitors.

Treatment:

Drug: PD-1 inhibitor

non-PD-1-treated tumor patients

Description:

Tumor patients who are initiating receive chemotherapy that not includes PD-1 inhibitors.