NCT04616040尚未招募不适用
A Non-interventional Registration Study Evaluating the Usage of Camrelizumab in the Treatment of Unresectable Locally Advanced/Recurrent or Metastatic Chinese Patients With Esophageal Cancer
Peking University1 个研究点 分布在 1 个国家目标入组 1,030 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,030
- 试验地点
- 1
- 主要终点
- Adverse events of Camrelizumab
研究概览
简要总结
The trial is a multi-center, open, observational registration study, which aims to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) in the treatment of Chinese patients with advanced esophageal cancer in the real world.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent and voluntarily participate in this study.
- •Unresectable locally advanced/recurring or distant metastatic esophageal cancer patients confirmed by histology or cytology (AJCC 8th edition);
- •Unresectable locally advanced patients who are unable or unable to receive radical treatment (including radical radio chemotherapy or radical radiotherapy, etc.) may be considered for inclusion;
- •Patients who progress or relapse after neoadjuvant or adjuvant therapy may also be considered for inclusion;
- •Age ≥ 18 years old;
- •The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.
排除标准
- •Evidence suggests that the patient is pregnant or breastfeeding;
- •Other drug blinded clinical trials are currently underway;
- •Other situations that are not suitable for inclusion in this study.
研究组 & 干预措施
unresectable locally advanced/recurrent or metastatic esophageal cancer
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Adverse events of Camrelizumab
时间窗: an expected average of 24 months
especially Occurrence of ≥Grade 3 immune-related AEs
次要结局
- Progression-free Survival (PFS)(an expected average of 24 months)
- Objective Response Rate (ORR)(an expected average of 24 months)
- Adverse events of Camrelizumab(an expected average of 24 months)
- Overall Survival(an expected average of 24 months)
研究者
Shen Lin
Professor
Peking University
研究点 (1)
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