Phase Ib Clinical Trial of Sorafenib in Combination With Transarterial Chemoembolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Safety and toxicity as assessed by NCI CTCAE v3.0 criteria
研究概览
简要总结
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride and mitomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking the blood flow to the tumor. Giving sorafenib tosylate together with chemoembolization may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of sorafenib tosylate when given together with chemoembolization with doxorubicin hydrochloride and mitomycin in treating patients with liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the safety of sorafenib tosylate when given in combination with transarterial chemoembolization (TACE) comprising doxorubicin hydrochloride and mitomycin C in patients with unresectable hepatocellular carcinoma.
Secondary
- To estimate the time to progression (TTP) in patients treated with this regimen.
- To estimate the overall survival (OS) of patients treated with this regimen.
- To explore correlative relationships between measures of serum VEGF in the peri-procedure TACE period and changes with TACE and sorafenib tosylate as well as patient outcomes (TTP and OS).
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm
Single Arm Trial
干预措施: doxorubicin hydrochloride (Drug)
Single Arm
Single Arm Trial
干预措施: mitomycin C (Drug)
Single Arm
Single Arm Trial
干预措施: sorafenib tosylate (Drug)
Single Arm
Single Arm Trial
干预措施: laboratory biomarker analysis (Other)
Single Arm
Single Arm Trial
干预措施: pharmacological study (Other)
结局指标
主要结局
Safety and toxicity as assessed by NCI CTCAE v3.0 criteria
时间窗: 3 years
次要结局
- Overall survival(5 years)
- Correlative studies(3 years)