NCT01429961Unknown2 期
Phase II Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma
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 18 years or older
- •ECOG performance score of two or less
- •Child Pugh class A•
- •Histologically or cytologically confirmed HCC or clinical diagnosis of HCC when the following criteria are all met History of chronic hepatitis or cirrhosis of liver Typical features of HCC demonstrated in dynamic imaging studies, such as three phase computed tomography AFP level more than 200 ng/mL
- •presence of extrahepatic measurable lesion
- •no prior systemic therapy (excluding sorafenib)
- •adequate marrow, liver, kidney function
- •written informed consent
排除标准
- •prior systemic therapy (excluding sorafenib)
- •hypersensitivity to study drugs
- •active gastrointestinal bleeding
- •other malignancies within five years
- •pregnant or breastfeeding female
- •symptomatic brain or leptomeningeal metastasis
- •clinically significant heart disease
- •interstitial pneumonia
- •peripheral neuropathy grade one or more
- •uncontrolled infection
- •renal impairment
- •prior use of investigational drug or therapy within 4 weeks
研究组 & 干预措施
SOX
Experimental
TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14
干预措施: SOX (Drug)
结局指标
主要结局
Time to progression (TTP)
时间窗: 2 years
The time from study enrollment to tumor progression or death
次要结局
- response rate(2 years)
- toxicity(2 years)
- overall survival(2 years)
研究者
研究点 (1)
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