Arterial Thromboembolism, Immune Checkpoint Inhibitors (ICIs), Lung Cancer, Venous Thromboembolism
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Beijing Chao Yang Hospital
Capital Medical University
China-Japan Friendship Hospital
The First Affiliated Hospital of Zhengzhou University
The Fourth Hospital of Inner Mongolia Autonomous Region
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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. | 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. |
| Overall survival | 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. | 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." |
| Objective response rate | From the date of the first dose of immune checkpoint inhibitors until the best efficacy is achieved, assessed up to 96 months. | 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. |
Countries
China
Contacts
CONTACTYuhui Zhang
Outcome results
None listed