NCT00280618已完成2 期
Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 主要终点
- Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST
研究概览
简要总结
Primary:
- To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin
Secondary:
- Safety and tolerability of this regimen in these patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients must have histologically confirmed hepatocellular carcinoma
- •Patients must have measurable disease by CT scan
- •Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy.
- •The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds.
- •WHO performance status: 0 to 2
- •Patients must have adequate organ and marrow function as defined below:
- •Leukocytes : ≥ 3,000/μl
- •Absolute neutrophil count :≥ 1,500/μl
- •Platelets : ≥ 80,000/μl
- •Total bilirubin : < 3.0g/dl
- •ASAT/ALAT : ≤ 3 times the upper normal limits of the institute
- •Creatinine : < 120μmol/l
- •Patients with no evidence of clinically significant neuropathy.
排除标准
- •Documented allergy to platinum compound or to others study's drugs
- •Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
- •Hematological disorder or malignancies
- •Metastasis to central nervous system
- •Other serious illness or medical conditions:
- •Active infectious disease
- •Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia.
- •Concurrent treatment with any other anticancer therapy
- •Concurrent treatment with other experimental drugs.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST
时间窗: During the Study Conduct
次要结局
- Adverse Events collections and evaluation(From the signature of the informed consent up to the end of the study)
研究者
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