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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT04710758
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-75 years
2. Tumor located in the middle or upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
3. Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
4. Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system);
5. Expected survival \> 6 months
6. No invasion to Z-line;
7. BMI (Body Mass Index) \< 30 kg/m2
8. No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
9. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc
10. Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
11. Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
12. Sufficient organ functions
13. Written informed consent
Exclusion Criteria:
1. Preoperative examinations indicate regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes
2. Women during pregnancy or breast-feeding
3. Synchronous or metachronous (within 5 years) malignancies
4. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
5. Severe mental disease
6. Severe respiratory disease, FEV1 \< 50% of predicted
7. Severe hepatic and renal dysfunction
8. Unstable angina pectoris or history of myocardial infarction within 6 months
9. History of cerebral infarction or cerebral hemorrhage within 6 months
10. Continuous systemic steroid therapy within 1 month (except for topical use)
11. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery
12. Patients are participating or have participated in another clinical trial (within 6 months)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04710758
Study Brief:
Protocol Section:
NCT04710758