Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Progression-free survivial
研究概览
简要总结
To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer
详细描述
evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed colorectal adenocarcinoma
- •Disease limited to the liver Unresectable disease by surgery or other local therapies
- •Age >18 years
- •ECOG performance status 0-2,Child pugh A or B
- •Expected survival ≥ 3 months
- •Adequate hematological, hepatic, and renal function
排除标准
- •Pregnant or lactating women
- •Patients with severe organ dysfunction or failure
- •With severe cardiovascular disease, or mental
- •Extraliver metastases
研究组 & 干预措施
Raltitrexed and Oxaliplatin
Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.
干预措施: Raltitrexed (Drug)
Raltitrexed and Oxaliplatin
Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.
干预措施: Oxaliplatin (Drug)
Raltitrexed and Oxaliplatin
Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.
干预措施: lipiodol (Drug)
结局指标
主要结局
Progression-free survivial
时间窗: 8 months after last patient randomized
From date of randomization until date of first documented PD, date of death
次要结局
未报告次要终点