Phase 2 Study of Neoadjuvant Bevacizumab Plus DOF Versus DOF in Local Advanced Gastric Carcinoma and Its Association With Circulating Tumor Cell
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0 resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough. Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy has been shown effective in advanced GC. In addition, CTC has been suggested as an indicator of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators plan to evaluate the efficacy and safety of neoadjuvant Bev plus docetaxel/oxaliplatin/5-FU/CF (DOF) versus DOF in mainly gastric antrum LAGC, and to investigate whether CTC is an effectiveness indicator.
Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1) to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was detected every 8 weeks. All patients signed the informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally advanced adenocarcinoma of the stomach.
- •Age of 18 to 70, Karnofsky score higher than
- •T3-4，N1-3，M0 (AJCC 7th), potentially resectable.
- •No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
排除标准
- •Clinical findings of distant metastasis or Peritoneal carcinomatosis
- •Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen
- •Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- •Upper gastrointestinal bleeding
- •Any contraindication to treatment with docetaxel, 5-fu or oxaliplatin
研究组 & 干预措施
bevacizumab plus DOF
patients receive bev +DOF pre and post surgery up to total 6 cycles
干预措施: Gastrectomy (Procedure)
DOF
patients receive DOF pre and post surgery up to total 6 cycles
干预措施: Gastrectomy (Procedure)
bevacizumab plus DOF
patients receive bev +DOF pre and post surgery up to total 6 cycles
干预措施: docetaxel oxaliplatin 5-FU CF (Drug)
DOF
patients receive DOF pre and post surgery up to total 6 cycles
干预措施: docetaxel oxaliplatin 5-FU CF (Drug)
bevacizumab plus DOF
patients receive bev +DOF pre and post surgery up to total 6 cycles
干预措施: Bevacizumab (Biological)
结局指标
主要结局
R0 resection rate
时间窗: 6-12 weeks after administration
次要结局
- pCR rate(Day 1 after surgery)
- safety of peroperative treatment and surgery(from first administration to 28 days after last administration)
- OS(3 years after surgery)
- DFS(3 years after surgery)
- ORR(6 weeks after administration)
研究者
DuNan
professor
Chinese PLA General Hospital