TACE Associated With Systemic Chemotherapy Versus Systemic Chemotherapy in Patients Who Failed With First Line Chemotherapy
试验速览
- 阶段
- 3 期
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
To date no randomized controlled trials have been completed that demonstrated whether TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversion resection rates and survival compared with chemotherapy (target therapy) alone for patients who failed with first-line chemotherapy.The primary objective of this trial is to determine conversion resection rates and survival for patients with colorectal cancer liver metastasis are treated with TACE plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd line.
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 CRLM
- •disease limited to the liver Unresectable disease by surgery or other local therapies
- •Age > 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2,child pugh A or B
- •Expected survival ≥ 3 months
- •Adequate hematological, hepatic and renal function
- •PD(progressive disease) after first line chemotherapy
排除标准
- •pregnant or lactating women
- •patients with severe organ dysfunction or failure
- •with severe cardiovascular or mental disease
研究组 & 干预措施
Arm A
TACE plus chemotherapy ± target therapy
干预措施: TACE (Drug)
Arm A
TACE plus chemotherapy ± target therapy
干预措施: chemotherapy±target therapy (Drug)
Arm B
chemotherapy ± target therapy
干预措施: chemotherapy±target therapy (Drug)
结局指标
主要结局
Progression free survival
时间窗: 6 months
次要结局
- overall survival(6 months)
- conversion resection rates(2-4months)