EUCTR2016-001514-20-PT进行中（未招募）1 期
A Randomized Phase 3 Study of Nivolumab plus Ipilimumab or Nivolumab Combined with Fluorouracil plus Cisplatin versus Fluorouracil plus Cisplatin in Subjects with Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma - CheckMate 648
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,127
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
- •- Male or Female at least 18 years of age
- •- Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
- •- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- •- Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment
- •in this study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 451
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 676
排除标准
- •- Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment.
- •- Active known or suspected autoimmune disease
- •- Any serious or uncontrolled medical disorder or active infection
- •- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •- Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus.
研究者
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