A Randomized, Controlled Phase II Study to Compare Preoperative Chemotherapies in Locally Advanced Gastric/Gastroesophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- major Pathological response rate
研究概览
简要总结
This is a randomized, phase II, open-label study. The purpose of this study is to determine the optimal treatment for patients with locally advanced Gastric/Gastroesophageal Cancer according to their HER-2 expression status.
The primary endpoint of this study: major pathology response rate the second endpoints of this study: pathology complete response rate R0 resection rate Progression-free survival ( PFS) Disease -free survival (DFS) Overall survival(OS) Objective response rate(ORR) Adverse event(AE)
详细描述
(HER2, human epidermal growth factor receptor-2) positive patients: After 4 cycles of SOX±Trastuzumab neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive 4 cycles of SOX±Trastuzumab adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.
(HER2, human epidermal growth factor receptor-2,HER2) negative patients： After 4 cycles of DOS or SOX regimen as neoadjuvant therapy, patients will continue to accept D2 surgery. The patients with R0 resection will continue to receive then 4 cycles of DOS or SOX adjuvant chemotherapy. If the patients are confirmed with tumor progression before surgery, the treatment such as gastrectomy, chemoradiotherapy or second line chemotherapy should be determined by MDT team.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Her2 Positive with SOX
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
干预措施: S-1 (Drug)
Her2 Positive with SOX
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
干预措施: Oxaliplatin (Drug)
Her2 Positive with SOXT
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks.
干预措施: S-1 (Drug)
Her2 Positive with SOXT
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks.
干预措施: Trastuzumab (Drug)
Her2 Positive with SOXT
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), trastuzumab 8mg/kg (loading dose), 6mg/kg subsequently ivgtt d1, every 3 weeks.
干预措施: Oxaliplatin (Drug)
Her2 Negative with SOX
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
干预措施: S-1 (Drug)
Her2 Negative with SOX
Oxaliplatin 130 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) ,100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
干预措施: Oxaliplatin (Drug)
Her2 Negative with DOS
Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) , 100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
干预措施: S-1 (Drug)
Her2 Negative with DOS
Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) , 100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
干预措施: Oxaliplatin (Drug)
Her2 Negative with DOS
Docetaxel 60 mg/m2, ivgtt, d1; Oxaliplatin 100 mg/m2, ivgtt, d1; S-1 twice a day depending on body surface areas (BSA) po d1-14, 80mg/day (BSA <1.25m2) , 100mg/day (BSA ≥1.25m2, <1.5 m2), 120mg/day (BSA ≥1.5m2), every 3 weeks.
干预措施: Docetaxel (Drug)
结局指标
主要结局
major Pathological response rate
时间窗: 40 months
次要结局
未报告次要终点
研究者
Aiping Zhou
Chief physician
Chinese Academy of Medical Sciences