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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT02269904
Eligibility Criteria:
Inclusion Criteria:
1. primary gastric cancer, Phase III
2. D2 radical gastrectomy(R0)
3. 18 year old or above
4. KPS≥70%；
5. suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L
6. suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN.
7. suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment .
9\. the authorized ICF must be signed
Exclusion Criteria:
1. non-initial gastric cancer；
2. having the other uncontrolled diseases.
3. obvious loss of weight ( more than 10% within 6 weeks )
4. the female in pregnancy or feeding.
5. contraindication to study drug
6. participating in other clinical trial and at the time of treatment period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02269904
Study Brief:
Protocol Section:
NCT02269904