NCT02350686Unknown2 期
Phase II Study of Second Line Capecitabine Plus Oxaliplatin (XELOX) in Patients With Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.
详细描述
XELOX
- Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks
- Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).
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
- •histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
- •unresectable or metastatic
- •progression after treatment with first line gemcitabine-based chemotherapy
- •ECOG performance status of 0~2
- •measurable or evaluable lesion per RECIST 1.1 criteria
- •adequate marrow, hepatic, renal and cardiac functions
排除标准
- •severe co-morbid illness or active infections
- •pregnant or lactating women
- •History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
- •active CNS metastases not controllable with radiotherapy or corticosteroids
- •known history of hypersensitivity to study drugs
研究组 & 干预措施
capecitabine+oxaliplatin
Experimental
XELOX every 3 weeks
干预措施: capecitabine (Drug)
capecitabine+oxaliplatin
Experimental
XELOX every 3 weeks
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 12months
次要结局
- response rate(12months)
- duration of response(12months)
- overall survival(12months)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(24months)
研究者
Ho Yeong Lim
MD, PhD, Division of Hematology-Oncology, Department of Medicine
Samsung Medical Center
研究点 (1)
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