NCT02322593已完成3 期
An Open-label Randomized Multi-center Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 711
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.
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
- •Patients who are diagnosed as gastric cancer.
- •No prior treatment for gastric cancer.
- •Negative or unknown for HER2 testing.
- •ECOG performance status of 0 or
排除标准
- •Unmanageable diarrhea.
- •Current peripheral sensory neuropathy or paresthesia.
- •Pregnant or lactating female.
研究组 & 干预措施
TAS-118/Oxaliplatin
Experimental
TAS-118 plus Oxaliplatin
干预措施: TAS-118 plus Oxaliplatin (Drug)
S-1/Cisplatin
Active Comparator
S-1 plus Cisplatin
干预措施: S-1 plus Cisplatin (Drug)
结局指标
主要结局
Overall Survival
时间窗: A survival follow-up was required every 12 weeks from the date of randomization to the date of death from any cause, whichever came first, assessed up to 38 months.
The primary endpoint was OS, which was defined as the time from the date of randomization to the date of death from any cause. Surviving patients were censored at the cutoff date or last contact date if lost to follow-up, or upon withdrawal of consent.
次要结局
- Time to Treatment Failure(From the date of randomization to the date of the last administration of the study drug.)
- Progression-free Survival(A radiographic imaging examination using CT or MRI was repeated every 6 weeks. Tumor assessments were performed from the date of randomization to the date of disease progression or death from any cause, whichever came first.)
- Disease Control Rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.)
- Overall Response Rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months.)
研究者
研究点 (1)
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