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Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

ConditionsLung CancerVenous ThromboembolismArterial ThromboembolismImmune Checkpoint Inhibitors (ICIs)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Chao Yang Hospital

About this trial

The purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are:

1. What is the real-world incidence of VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 2. What are the risk factors and biomarkers for VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 3. What is the impact of VTE/ATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors?

Researchers will compare the characteristics and biomarkers of patients with and without ICI-associated VTE/ATE to identify novel specific biomarkers for thrombotic events. Furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Histopathologically confirmed lung cancer diagnosis at enrollment

Received at least one dose of a China-approved lung cancer immune checkpoint inhibitor

Signed informed consent form

Disqualifiers

Presence of two or more primary cancers

Missing data for key variables

Inability to comply with follow-up requirements

Presence of VTE/ATE at the time of ICI initiation

Trial population

Adult patients with histopathologically confirmed lung cancer who were treated with immune checkpoint inhibitors between January 1, 2019, and December 31, 2026.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,400 Participants
are grouped into 4 trial groups
Group A: With immune checkpoint inhibitor-associated venous thromboembolism
Group B: Without immune checkpoint inhibitor-associated venous thromboembolism
Group C: With immune checkpoint inhibitor-associated arterial thromboembolism
Group D: Without immune checkpoint inhibitor-associated arterial thromboembolism

Trial outcomes

Primary outcomes

1

Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism

From the administration of the first dose of immune checkpoint inhibitors until death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, symptomatic and incidentally detected arterial thromboembolism and venous thromboembolism events that occur during this period are included.

Time frame
Begin on the date of the first ICI dose and end upon death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, whichever comes first, assessed up to 96 months.

Secondary outcomes

1

Progression-free survival

Progression-Free Survival refers to the time from the start of immune checkpoint inhibitor therapy until the disease progresses or the patient dies, whichever occurs first.

Time frame
From the date of the administration of the first dose of immune checkpoint inhibitors until the date of disease progression, death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.
2

Overall survival

Overall survival refers to the time from the start of immune checkpoint inhibitor therapy until the patient dies or the cutoff date, whichever occurs first."

Time frame
From the date of the administration of the first dose of immune checkpoint inhibitors until the date of death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.
3

Objective response rate

Objective Response Rate (ORR) refers to the proportion of patients who experience a confirmed reduction in tumor size or complete disappearance of the tumor, as assessed by standard criteria such as RECIST (Response Evaluation Criteria in Solid Tumors). It includes both complete responses (CR) and partial responses (PR) and is typically reported as a percentage of the total treated population.

Time frame
From the date of the first dose of immune checkpoint inhibitors until the best efficacy is achieved, assessed up to 96 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Chao Yang Hospital

Lead sponsor

Capital Medical University

Collaborator

China-Japan Friendship Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

The Fourth Hospital of Inner Mongolia Autonomous Region

Collaborator

Source ClinicalTrials.gov
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