Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Median Progression-free Survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy 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 chemotherapy drugs directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together with chemoembolization may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy.
Secondary
- Characterize the safety and toxicity of this regimen in these patients.
- Determine the response rate in patients treated with this regimen.
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, received bevacizumab and TACE
干预措施: bevacizumab (Biological)
single arm, received bevacizumab and TACE
干预措施: chemotherapy (Drug)
single arm, received bevacizumab and TACE
干预措施: embolization therapy (Drug)
single arm, received bevacizumab and TACE
干预措施: hepatic artery infusion (Procedure)
结局指标
主要结局
Median Progression-free Survival
时间窗: Time through study completion, an average of 1 year
This outcome was not assessed. Instead, the primary outcome of time to tumor progression (TTP) of the targeted lesions and secondary outcomes of TTP of nontargeted lesions and overall TTP were assessed and reported.
Time to Tumor Progression (TTP) of Targeted Lesions
时间窗: 6 months and 1 year
Time to tumor progression was estimated via Kaplan-Meier methodology using the 23 patients who underwent treatment.
次要结局
- Overall Survival (OS)(1 year)
- Response Rate - Based on Tumor Enhancement(6 months)
- Safety and Treatment Toxicity - Cycle 1 Post-TACE(Cycle 1 post-TACE - 5 weeks)
- TTP of Nontargeted Lesions Within the Liver(1 year)
- Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)(6 months)
- Safety and Treatment Toxicity - Cycle 1 Pre-TACE(Cycle 1 pre-TACE - 2 weeks)
- TTP Rate at 6 Months and 1 Year(6 months and 1 year)
- Safety and Treatment Toxicity - Cycles 2 and 3(6 months)
- Overall TTP(1 year)