NCT00351195终止2 期
A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Response
研究概览
简要总结
Various cytotoxic agents have been evaluated in advanced hepatocellular carcinoma, but response rates have been low with significant toxicity, most often due to parenchymal liver disease. The three agents etoposide, oxaliplatin and capecitabine each has sparse efficacy as single agents, but the combination may act synergistically with an acceptable toxicity profile.
详细描述
Design:
Open phase II study.
Purpose:
Response rate for the combination of etoposide, oxaliplatin and capecitabine given every 3 weeks on an outpatient basis.
Secondary endpoint are safety, time to progression and survival
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein > 400 ng/ml
- •Age 18-75
- •Life expectancy > 12 weeks
- •Normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)
- •Bilirubin < 2 x UNL
- •Transaminases < 3 x UNL
- •Normal renal function, Cr-EDTA clearance > 50 ml/min
- •No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
- •No uncontrolled, severe concurrent medical disease
- •Fertile women must have a negative pregnancy test
- •Fertile women must use adequate contraceptives during and 3 months after trial exposure
- •Signed informed consent
排除标准
- •Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
- •Experimental therapy < 8 weeks prior to inclusion
- •Known DPD-deficiency
- •Known neuropathy
- •Uncontrolled, severe concurrent medical disease
- •Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
结局指标
主要结局
Response
次要结局
- Time to progression
- Safety
- Survival
研究者
研究点 (2)
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