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:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT05507658
Eligibility Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent;
2. Aged 18-80 (including 18 and 80), both sexes;
3. ECOG score ≤1;
4. Biopsy histologically confirmed adenocarcinoma (including Lauren grade);
5. cT3-4a N+ M0 G/GEJ adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced CT (PET/CT), MRI or diagnostic laparoscopy;
Exclusion Criteria:
1. Histological histological diagnosis of squamous cell carcinoma (adenosquamous carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated carcinoma or other unclassified carcinoma;
2. Patients with HER2-positive status are excluded;
3. Patients with distant metastases other than primary gastric cancer (any M1 stage);
4. Patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant chemotherapy);
5. Patients who can not undergo radical surgical resection (D2 radical resection);
6. Previous antitumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy and hormone therapy);
7. Previously received immunological drugs such as PD-1/PD-L1, CTLA-4 or other immunological or molecular targeted therapies;
8. When virological testing prior to screening showed any of the following:
1. patients with active hepatitis (HBV DNA≥1\*103 copies or ≥200IU/mL);
2. Anti - HCV positive;
3. HIV positive;
9. Patients or their families refused to sign this informed consent form to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05507658
Study Brief:
Protocol Section:
NCT05507658