Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 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 sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).
详细描述
Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for A/MGC patients as a second line treatment.
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)
- •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
- •Uncontrolled significant comorbid conditions and previous radiotherapy
研究组 & 干预措施
A
administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: sorafenib (Drug)
结局指标
主要结局
time to progression
时间窗: every six weeks
次要结局
- toxicity(6 weeks)