Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT05313906
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years old, ≤75 years old, regardless gender
* Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+
* ECOG PS scores 0-1
* Stage IV according to AJCC 8.0 and no systemic therapy previously
* Expected lifespan ≥ 3 months
* Adequate organ function
* At least one measurable lesion according to RECIST 1.1
* Asymptomatic intracranial metastasis
* No history of other malignancies
* Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial
* Agreed to participate in this clinical study and signed the Informed Consent
Exclusion Criteria:
* Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose
* Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor
* Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration
* Active autoimmune diseases or immunodeficiency diseases
* Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug
* Severe mental disorder
* Receiving systemic corticosteroids within 7 days prior to the first dose of the study
* Clinically apparent cardiovascular and cerebrovascular disease
* Others investigators evaluated not meet the inclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05313906
Study Brief:
Protocol Section:
NCT05313906