這是一項單中心隨機對照試驗,比較圍手術期FLOT與輔助XELOX用於局部晚期胃癌及胃食道交界癌。將招募可手術的臨床T3或以上及N1或以上的胃癌及胃食道交界癌患者。參與者將被隨機分配接受圍手術期FLOT或輔助XELOX,並接受根治性胃切除術。主要終點為3年無病存活期。
適應症:Cancer of Stomach, Adenocarcinoma
收案條件
納入條件
- Locally advanced adenocarcinoma of stomach or esophagogastric junction (Siewert type II and III), defined by clinical stage ≥T3 and/or ≥N1, in the absence of distant metastasis
- Surgically resectable disease based on clinical staging
- No previous gastrectomy or chemotherapy
- Age 18 or above but less than 80, and
- ECOG ≤2
- Hemoglobin \>/= 8.0 g/dL
- Neutrophils \>/= 1.500/µl
- Platelets ≥ 100.000/µl
- Creatinine clearance ≥ 50 ml/min
- Serum albumin \>25 g/L
排除條件
- Distant metastases, direct tumor invasion to organs not resectable by surgery
- Hypersensitivity or contraindication against Capacitabine, 5-FU, Leucovorin, Oxaliplatin, Docetaxel
- Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
- Peripheral polyneuropathy ≥ NCI grade II
- Severe liver dysfunction (i) ALT \>3 x upper limit of normal, and/ or (ii) total bilirubin \>1.5 x upper limit of normal (subjects with Gilbert Syndrome with total bilirubin level of \>/= 3.0 x upper limit of normal)
- Pregnancy or lactation
- Malignant secondary disease, dated back \<5 years (except in-situ carcinoma of cervix uteri, adequately treated skin basal cell carcinoma)
- Serious uncontrolled infection or cocomitant severe medical conditions
收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。