招募中 NCT05264896

胃癌圍手術期FLOT與輔助XELOX之比較

胃癌皮膚癌Phase IIIIII 期IV 期

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。