Phase I Study: Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer as Adjuvant Setting (NORDICA)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 主要终点
- Recommended dose for Phase II study
研究概览
简要总结
Investigators assessed the effectiveness of Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting
详细描述
Adjuvant chemotherapy is still the standard of care for stage Ⅲ gastric cancer. Till now, oxaliplatin with capecitabine or S1 still the standard chemotherapy regimen. Howerver, the prognosis of diffuse type gastric cancer patients is still poor even after adjuvant chemotherapy of XELOX or S1 regimen. Several retrospective, single institutional studies have shown that the addition of Nab-paclitaxel to S1 can prolong the survival of advanced gastric cancer with diffuse type.However, the effection of Nab-paclitaxel and S1 is unknown in diffuse gastric cancer patients after radical surgery. We assessed the effectiveness of radical surgery following docetaxel, nab-pacitaxel and S1 therapy for gastric cancer with diffuse type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gastric cancer patients after radical resection
- •diffuse type gastric cancer stage III
排除标准
- •Patients who have metastasis disease
- •Patients who can not tolerate chemotherapy
研究组 & 干预措施
Nab-paclitaxel combined with S-1
Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting
干预措施: Nab-paclitaxel combined with S-1 (Drug)
结局指标
主要结局
Recommended dose for Phase II study
时间窗: through study completion, an average of 2 year
次要结局
未报告次要终点
研究者
Tianshu Liu
Chairman for the department of oncology
Shanghai Zhongshan Hospital