A Randomized, Open-label, Japan-Korea-Taiwan Collaborative Phase 3 Study to Compare the Efficacy of Nimotuzumab and Irinotecan Combination Therapy Versus Irinotecan Monotherapy as Second Line Treatment in Subjects With Advanced or Recurrent Gastric and Gastroesophageal Junction Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Overall Survival
研究概览
简要总结
This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.
详细描述
This randomized, open-label, Japan, Korea and Taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. Approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control group) or nimotuzumab and irinotecan (combination group). Nimotuzumab and/or irinotecan should be continued until disease progression or intolerable toxicity. Nimotuzumab is administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered at 150 mg/m2 once every 2 weeks as an intravenous infusion.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma.
- •Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent.
- •Subjects with EGFR overexpression (2+ or 3+ in IHC)
排除标准
- •Subjects who have received irinotecan
- •Subjects who have received EGFR-directed therapy
- •Other active malignancy within the last 5 years
研究组 & 干预措施
Irinotecan and nimotuzumab
Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
干预措施: Irinotecan (Drug)
Irinotecan and nimotuzumab
Adminitration of irinotecan 150 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly
干预措施: Nimotuzumab (Drug)
Irinotecan
Administration of irinotecan 150 mg/m2 IV once every 2 weeks
干预措施: Irinotecan (Drug)
结局指标
主要结局
Overall Survival
时间窗: Around 4.5 years after first subject randomization
Overall survival is defined as the time from the date of randomization to the date of the death from any cause.
次要结局
- Incidence of adverse events(Around 4.5 years after first subject randomization)
- Overall Response Rate(Around 4.5 years after first subject randomization)
- Progression Free Survival(Around 4.5 years after first subject randomization)
- Disease Control Rate(Around 4.5 years after first subject randomization)