ONO-4538 Phase III Study A Multicenter, Randomized, Open-label Study in Patients With Esophageal Cancer Refractory or Intolerant to Combination Therapy With Fluoropyrimidine and Platinum-based Drugs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 58
- 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 Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
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
- •Men & women ≥20 years of age
- •Histologically confirmed unresectable advanced or recurrent esophageal cancer
- •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
Nivolumab Arm
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Nivolumab (Drug)
Active Comparator Arm （Docetaxel/Paclitaxel）
Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
OR
Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
干预措施: Docetaxel/Paclitaxel (Drug)
结局指标
主要结局
Overall Survival
时间窗: ("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive.
次要结局
- Duration of Response(("Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause" - "Date of first assessment of confirmed CR or PR" + 1) / 30.4375.)
- Progression-free Survival(("Earlier date on which either the overall response was assessed as PD or the subject died of any cause" - "Date of randomization" + 1) / 30.4375.)