The Second Affiliated Hospital of Zhejiang University
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 360
- 试验地点
- 9
- 主要终点
- Objective response rate
研究概览
简要总结
This study is a multicenter ,randomization, open control study to evaluate the efficacy and safety of Raltitrexed-based chemotherapy and 5-fluorouracil-based chemotherapy in the peri-operative treatment of patients with Liver Metastasis From colorectal cancer (CRC).
详细描述
The contrast analysis is separately done on Raltitrexed plus oxaliplatin and 5-fluorouracil plus oxaliplatin;Raltitrexed plus irinotecan and 5-fluorouracil plus irinotecan.To investigate the objective response rate,the R0 resection rate, the early tumor shrinkage （ETS）and depth of response(DPR) and the safety profile.
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
- •Histologically confirmed chinese colorectal cancer patients and imaging detection confirmed liver metastasis
- •previously no treatment for liver metastasis or Primary tumor had been removed and last additional chemotherapy over one year
- •Age of≥18 and ≤75
- •Adequate organ functions, as determined by normal bone marrow function (absolute neutrophil count2 x 109/L, platelets 100 x 109/L, White blood cells 4 x 109/L), liver function (serum bilirubin ≤ 2.5 x ULN, serum transaminases ≤
- •Life Expectancy>6months
- •Signed written informed consent
- •Expected adequacy of follow-up
排除标准
- •Lesion is too small to assess by imaging
- •Extrahepatic metastases
- •Any anticancer chemotherapy in development within 4 weeks prior to study entry
- •Concurrent uncontrolled illness such as infection
- •Be allergic to medicines in the study
- •Pregnant or nursing patients
- •Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
- •Not willing or incapable to comply with all study visits and assessments
- •Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.
研究组 & 干预措施
Raltitrexed-based chemotherapy
Raltitrexed plus Oxaliplatin/Raltitrexed plus Irinotecan
干预措施: Raltitrexed-based chemotherapy (Drug)
5-fluorouracil-based chemotherapy
5-fluorouracil plus Oxaliplatin/5-fluorouracil plus Irinotecan
干预措施: 5-fluorouracil-based chemotherapy (Drug)
结局指标
主要结局
Objective response rate
时间窗: 38 months
次要结局
- R0 resection rate of liver(38 months)
研究者
Ding Ke-Feng
the Second Affiliated Hospital of Zhejiang University
Zhejiang University