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:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01889303
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent
2. Age \> 19
3. Histologically proven gastric or gastroesophageal adenocarcinoma
4. ≥ D2 lymph node dissection, curative gastrectomy,
5. Stage T4 with or without any positive LN (AJCC 2010) ，No distant metastasis(M0) and after D2 radical gastrectomy
6. KPS≥70 or ECOG 0-2
7. R0 resection,
8. Adequate bone marrow functions (WBC≥4.0×109/L，GRAN≥2.0×109/L，Hb≥90g/L, transfusion allowed, PLT≥100×109/L )
9. No severe functional damage of major organ,and no uncontrolled or severe cardiopulmonary concurrent system disease
10. Adequate renal functions(serum creatinine ≤ 1.5×ULN ) ;liver functions (serum bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.5 times(normal value) ,serum AKP≤2.5×ULN
11. Predictive survival time longer than 6 months.
Exclusion Criteria:
1. pregnant or breast-feeding women;
2. Have received preoperative neoadjuvant therapy of gastric cancer
3. Before or at the same time with other malignant tumor, and underwent chemotherapy, immune, and biological treatment and radiation therapy;with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
4. uncontrolled mental disease
5. Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, no myocardial infarction within the last 12 months, unstable angina pectoris, or significant arrhythmia)
6. Active infection requiring antibiotics
7. Resection margin (+) at permanent pathology
8. Peripheral neuropathy symptoms, NCI class \> 1
9. severe malnutrition or severe anemia
10. uncontrolled Primary brain tumors or the central nervous system disease
11. Known hypersensitivity against any of the study drugs
12. Pathologic stage I-IIa or IV (according to AJCC 2010)
13. Inadequate surgery including D0, D1 resection, dissected LNs less than 12
14. Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT01889303
Study Brief:
Protocol Section:
NCT01889303