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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT03817268
Eligibility Criteria:
Inclusion Criteria:
* Microscopically-confirmed gastric adenocarcinoma (cardia cancer/adenocarcinoma of the esophagogastric junction);
* Cancer stage pT1N+M0 or pT2-3N0M0;
* Radical R0 resection;
* Retrieved lymph node number ≥15;
* Without hepatic, peritoneal, or other distant metastasis;
* Aged 18-70 years;
* No other cancer-directed therapy except primary cancer resection;
* Good tissue and organ function: white blood cell count ≥4000/mm3; neutrophil count ≥1500/mm3; platelet count ≥100000/mm3; total bilirubin ≤25.7 μmol/L or within 1.5 times the upper threshold; aspartate transaminase (AST) and alanine transaminase (ALT) within 2.5 times the upper threshold; creatinine within 1.25 times the upper threshold; creatinine clearance rate \>60 mL/min;
* No serious cardiovascular or cerebrovascular disease;
* No concomitant or previous malignancies;
* Enrolled within 6 weeks after resection;
* Eastern Cooperative Oncology Group (ECOG) score ≤2;
* Clavien-Dindo morbidity score 0-2;
* Patient informed consent.
Exclusion Criteria:
* The need to take phenytoin or coumarin anti-coagulates;
* Allergic to capecitabine or fluorouracil;
* Known DPD activity deficiency (DPYD gene mutation);
* Pregnant or breeding women;
* All others contradictory to the items listed in the Inclusion Criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03817268
Study Brief:
Protocol Section:
NCT03817268