Micro and Macro Arteriolar Blockade of Hepatocellular Carcinoma (HCC): Treatment With Sorafenib Before and After Hepatic Arterial Embolization (HAE) Therapy for Liver Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and tolerability as assessed by NCI CTCAE v3.0
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 C, 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 blood flow to the tumor. Giving sorafenib tosylate before and after chemoembolization may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib tosylate before and after hepatic arterial chemoembolization with doxorubicin hydrochloride and mitomycin C works in treating patients with localized liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To evaluate the safety and tolerability of sorafenib tosylate therapy when administered before and after doxorubicin hydrochloride-based hepatic arterial chemoembolization (HACE) as assessed by NCI CTCAE v3.0 in patients with localized unresectable hepatocellular carcinoma.
Secondary
- To determine if sorafenib tosylate decreases the number of HACE treatments required to achieve radiologic tumor kill.
- To assess improvement in progression-free survival.
- To assess changes in monthly AFP levels in patients with AFP-producing tumors.
- To measure VEGF levels.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sorafenib Tosylate, Doxorubicin, Mytomicin C
Micro and Macro arteriolar blockade of hepatocellular carcinoma (HCC): Treatment with Sorafenib 400mg two weeks prior to embolization HACE which includes the use of agents such as Doxorubicin Hydrochloride and Mytomicin C, continuing same Sorafenib dose after the procedure (dose adjustment according to tolerance).
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Safety and tolerability as assessed by NCI CTCAE v3.0
时间窗: 06/2009 to 12/2010
次要结局
- Number of hepatic arterial chemoembolization (HACE) treatments required to achieve objective complete response(06/2009 to 12/2010)
- Progression-free survival and time to radiologic progression as assessed by CT scan(06/2009 to 12/2010)
- Overall survival at 6, 12, and 24 months(06/2009 to 12/2011)
- AFP and VEGF serum levels as assessed at baseline, prior to each HACE treatment, and then every 3 months thereafter(06/2009 to 12/2011)
研究者
Andrew de la Torre
M.D
Rutgers, The State University of New Jersey