Caffeic Acid for Advanced Esophageal Squamous Cell Cancer: A Randomized, Double-blind, and Multicenter Trial in Chinese Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- overall survival (OS)
研究概览
简要总结
Caffeic acid can target inhibit GASC1 (gene amplified in squamous cell carcinoma 1, also known as KDM4C and JMJD2C) expression and GASC1 is confirmed to be a new oncogene in several cancers including esophageal cancer. This study aims to investigate the efficiency and safety of coffeic acid in chinese advanced esophageal squamous cell cancer (ESCC).
详细描述
Background: More than half of global esophageal cancer cases came from China.80 percentage patients were diagnosed with advanced disease and suffered from the poor outcome.With the development of target therapy among cancers,the overall survival and life quality of patients has been continuous improved recently.However,there had little reports focusing on target therapy in esophageal cancer . Caffeic acid as an ordinary drug is used for thrombocytopenia when patient received chemotherapy. Newly studies shown caffeic acid can target inhibit GASC1 expression, and GASC1 is confirmed to be a new oncogene in esophageal cancer.
Aim: to investigate the efficiency and safety of caffeic acid in chinese advanced esophageal squamous cell cancer.
Methods: 240 advanced ESCC patients will be randomized to two arms: Arm A (receiving coffeic acid treatment) or Arm B (placebo group). In Arm A, patients will receive coffeic acid treatment: 300mg, tid, po, continue to progress disease (PD) or die or the intolerant adverse events; in Arm B, the same shape placebo tablets will be deliveried to patients. 1 years follow-up for both groups patients.Patients in both arms can receive any other ways of anti cancer therapy in the same time.
Primary endpoints: OS Second endpoints: PFS
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •esophageal squamous cell cancer
- •stage IV or disease recurrence
- •chemotherapy, or radiotherapy, or palliative care is going on
排除标准
- •PS (performance status): ≥ 3
- •severe hepatic and renal dysfunction
- •hypercoagulability
- •thrombocytosis
研究组 & 干预措施
CA group
caffeic acid (300mg, tid, po) continue given until progression of disease or death, or patients are unable to bear the side effects
干预措施: CA (Drug)
placebo group
the same shape placebo tablets continue given until progression of disease or death, or patients are unable to bear the side effects
干预措施: placebo group (Drug)
结局指标
主要结局
overall survival (OS)
时间窗: 1 year
The percentage of 1 year overall survival (OS) after random allocation. The follow-up will be done every 3 months through phone call, investigator visiting, and medical recording review.
次要结局
- progression-free survival (PFS)(1 year)