Phase II Trial of Epirubicin Cisplatin and FU Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- time to progression
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerability of the ECF regimen (epirubicin, cisplatin and FU) combined with endostar-- a inhibitor of angiogenesis, in patients with advanced or metastatic gastric cancer (A/MGC).
详细描述
Although there is no standard regimen in the treatment of metastatic gastric cancer, ECF regimen (epirubicin, cisplatin and FU) is often considered as a reference regimen. And ECF regimen has been suggested as the first line therapy for A/MGC by FDA. According to the result of a Chinese phase III clinical trial in metastatic lung cancer, endostar-- a new angiogenesis inhibitor prolonged the overall survival, time to progression and improved response rate. So we designed this clinical trial to evaluate whether endostar can bring survival benefits to patients with advanced and metastatic gastric cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- •ECOG performance scale ≤ 2
- •At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- •Adequate hepatic, renal, heart, and hematologic functions (platelets>80×109/L, neutrophil> 2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase ≤ 2.5×the ULN)
排除标准
- •Pregnant or lactating women
- •Concurrent cancer
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Neuropathy, brain, or leptomeningeal involvement
- •Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
- •Uncontrolled significant comorbid conditions and previous radiotherapy
研究组 & 干预措施
A
patients will be treated by ECF regimen (epirubicin, cisplatin plus 5-FU) combined with endostar
干预措施: ECF-endostar (Drug)
结局指标
主要结局
time to progression
时间窗: every two cycles
次要结局
- toxicity(3 weeks)