招募中 NCT05264896

胃癌围手术期FLOT与辅助XELOX之比较

胃癌皮肤癌Phase IIIIII 期IV 期

这是一项单中心随机对照试验,比较围手术期FLOT与辅助XELOX用于局部晚期胃癌及胃食道交界癌。将招募可手术的临床T3或以上及N1或以上的胃癌及胃食道交界癌患者。参与者将被随机分配接受围手术期FLOT或辅助XELOX,并接受根治性胃切除术。主要终点为3年无病生存期。

适应症:Cancer of Stomach, Adenocarcinoma

入组条件

纳入标准

  • 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

排除标准

  • 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

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。