A Phase II, Prospective Study for Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression or Positive FISH as Second-line Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Objective response rates
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates.
详细描述
Epidermal growth factor receptor (EGFR) signaling is critical for cancer cell proliferation, invasion, metastasis, and resistance to apoptosis.EGFR is overexpressed in many epithelial malignancies and therefore makes an attractive therapeutic target.This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates. Secondary endpoints include progress-free survival, overall survival, safety and so on.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologic or cytologic diagnosis of carcinoma of the gastroesophageal junction or esophagus;
- •Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria;
- •Overexpression of EGFR defined by immunohistochemistry (3+) or gene amplification by fluorescence in-situ hybridisation;
- •Have progressed after one chemotherapy regimen;
- •Age 18-75 years old with performance status of 0 to 2
排除标准
- •Prior targeted therapy with erlotinib, gefitinib, and so on
- •Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
- •Known severe hypersensitivity to icotinib or any of the excipients of this product.
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
研究组 & 干预措施
Icotinib
Icotinib: 250 mg is administered orally three times per day, until disease progression or unacceptable toxicity.
干预措施: Icotinib (Drug)
结局指标
主要结局
Objective response rates
时间窗: 2 months
Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.
次要结局
- Progression Free Survival(5 months)
- Overall survival(9 months)