NCT02267343已完成3 期
ONO-4538 Phase III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent 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
- 493
- 试验地点
- 26
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of study is to evaluate the efficacy and safety of ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men & women ≥20 years of age
- •Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)
- •Histologically confirmed adenocarcinoma
- •Refractory to or intolerant of standard therapy
- •ECOG Performance Status score 0 or 1
- •A life expectancy of at least 3 months
排除标准
- •Current or past history of severe hypersensitivity to any other antibody products
- •Patients with multiple primary cancers
- •Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
- •Patients with active, known or suspected autoimmune disease
研究组 & 干预措施
Placebo Arm
Placebo Comparator
Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Placebo (Drug)
ONO-4538 Arm
Experimental
ONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: ONO-4538 (Drug)
结局指标
主要结局
Overall survival
时间窗: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
次要结局
- Duration of response(Up to study completion (estimated time frame: 30 months), every 6 weeks in principle)
- Progression-free survival(Up to study completion (estimated time frame: 30 months), every 2 weeks in principle)
- Objective response rate(Up to study completion (estimated time frame: 30 months), every 6 weeks in principle)
- Safety will be analyzed through the incidence of adverse events, serious adverse events(Continuously throughout study treatment and up to 28 days from last dose)
- Safety will be analyzed through the incidence of laboratory abnormalities(Continuously throughout study treatment and up to 28 days from last dose)
研究者
研究点 (26)
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