jRCT2080223754已完成3 期
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab plus Cisplatin, in Combination with Radiotherapy in Participants with Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN).(ONO-4538-66/CA2099TM )
ONO PHARMACEUTICAL CO.,LTD.1 个研究点目标入组 1,046 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,046
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Double-blind, Parallel Assignment, Randomized study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx
- •Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach
- •No previous radiotherapy or systemic treatment for SCCHN
排除标准
- •Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary
- •Clinical or radiological evidence of metastatic disease
- •Prior radiotherapy that overlaps with radiation fields
结局指标
主要结局
-
safety 1.Adverse events(AEs) 2.Serious adverse events(SAEs)
次要结局
未报告次要终点
研究者
研究点 (1)
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