Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.
详细描述
There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.
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
- •18-75 years old, male or female
- •Gastric cancer with measurable lesions, and the diameter is at least 1 cm
- •Karnofsky score: at least 70
- •Estimated survival: at least 6 months
- •No prior target therapy or radiotherapy
- •No severe hypertension, cardiac disease, or diabetes mellitus
- •Normal blood routine and chemical tests
- •Signed consent
排除标准
- •Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
- •Extensive distant metastases
- •Pregnancy or in lactation
- •Allergic to 5-Fluorouracil
研究组 & 干预措施
nimotuzumab
Combination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients.
干预措施: nimotuzumab (Drug)
结局指标
主要结局
progression-free survival
时间窗: 1 year progression-free survival
progression-free survival: the time between tumor regression to progression
次要结局
- overall responses(1 month after treatment)
- overall survival time(1 month after treatment)
研究者
Jing Jin, M.D.
vice chair of radiation department, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences