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。