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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07374250
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years.
2. Histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
4. Clinically staged as T3-4a N+ M0 by computed tomography (CT) or magnetic resonance imaging (MRI).
5. Considered eligible for curative resection.
6. No prior antitumor therapy for the current disease.
7. Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.
8. Expected survival of ≥6 months.
Exclusion Criteria:
1. Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.
2. Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.
3. Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.
4. History of thromboembolic or arterial/venous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.
5. Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07374250
Study Brief:
Protocol Section:
NCT07374250