NCT01127555已完成2 期
Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : older than 18
- •Histologically confirmed adenocarcinoma of the biliary tract
- •Metastatic or unresectable biliary cancer
- •Prior exposure to gemcitabine chemotherapy for biliary cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- •A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT
- •Adequate bone marrow, liver, renal function
排除标准
- •Pregnancy and breast-feeding.
- •Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
- •Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
- •Symptomatic or uncontrolled brain metastasis
结局指标
主要结局
Response rate
时间窗: 1 year
Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan
次要结局
- To evaluate the safety(1 year)
- To estimate the time to progression(1 year)
- To estimate overall survival(1 year)
研究者
In Gyu Hwang
Chung-Ang University Hospital
Chung-Ang University
研究点 (1)
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