Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Controlled Phase II/III Trial in China
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.
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 —（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
Systemic Chemotherapy plus Hepatic Artery Infusion (HAI)
干预措施: Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) (Drug)
Systemic Chemotherapy
干预措施: Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) (Drug)
结局指标
主要结局
Overall Survival
时间窗: 5-year
Overall survival will be measured from the date of randomization up to the date of death of any cause
Liver Relapse-Free Survival Rate
时间窗: 3-year
Liver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first.
次要结局
- Disease free survival(3-year)
研究者
Ye Xu
Professor
Fudan University