This study is a randomized, controlled, open-label, multicenter trial. Patients who underwent radical resection for stage IB-IIA gastric or gastroesophageal junction adenocarcinoma were enrolled and stratified into low-risk and high-risk groups based on the presence of lymph node metastasis, vascular invasion, or elevated preoperative tumor markers (CEA or CA19-9). Patients in the low-risk group were directly enrolled in follow-up observation, while those in the high-risk group were randomized 1:1 to either close follow-up or adjuvant chemotherapy. The primary endpoint of the study is the efficacy and safety of adjuvant chemotherapy following radical resection in patients with stage IB-IIA gastric or gastroesophageal junction adenocarcinoma.
1.Aged ≥18 years of either gender. 2.Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction with an ECOG performance status score ≤2.
Absolute neutrophil count (ANC) ≥1.5×10⁹/L without granulocyte colony-stimulating factor administration within the preceding 14 days;
Platelet count ≥100×10⁹/L without blood transfusion within the preceding 14 days;
Hemoglobin >9 g/dL without blood transfusion or erythropoietin administration within the preceding 14 days;
1. Other malignant tumors of the stomach. 2. Receipt of any anti-tumor therapy other than the chemotherapy specified in this protocol prior to screening or planned administration of such therapy during the trial (including radiotherapy, targeted therapy, immunotherapy, etc.).
Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA Grade ≥Ⅱ.
Resting electrocardiogram showing severe, symptomatic and refractory abnormalities in cardiac rhythm, conduction or morphology, including complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia or atrial fibrillation.
History of arterial thrombosis, embolism or ischemic events within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack.
Parallel
Tegafur Gimeracil Oteracil Potassium Capsules for oral administration
DrugTegafur Gimeracil Oteracil Potassium Capsules for oral administration, dosage regimen:Body surface area (BSA) \<1.25 m²: 40 mg per dose, twice daily; 1.25 m² ≤ BSA \<1.5 m²: 50 mg per dose, twice daily; BSA ≥1.5 m²: 60 mg per dose, twice daily. Medication is administered consecutively for 14 days followed by a 7-day drug-free interval to complete one treatment cycle, with a total of 8 cycles planned.
Disease-Free Survival (DFS) difference among three study arms after curative resection for stage IB-IIA gastric/gastroesophageal junction adenocarcinoma
Click on the lead sponsor to view all of their trials.
