NCT02376452Unknown2 期
Phase II Study of 2-weekly Raltitrexed Plus Irinotecan Regimen (RAILIRI) Versus Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) as Second-line Treatment in Advanced Colorectal Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
- •Eastern Cooperative Oncology Group performance status of 0 to 1
- •life expectancy of ≥ 3 months
- •patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
- •at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
- •have adequate bone marrow, hepatic, and renal function
排除标准
- •patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
- •patients with symptomatic brain metastases
- •active clinical severe infection
- •previously received irinotecan or raltitrexed
- •dihydropyrimidine dehydrogenase (DPD) enzyme adequate
研究组 & 干预措施
RALIRI
Experimental
Raltitrexed combined with irinotecan
干预措施: Raltitrexed (Drug)
RALIRI
Experimental
Raltitrexed combined with irinotecan
干预措施: Irinotecan (Drug)
FOLFIRI
Placebo Comparator
5-fluorouracil,folinate combined with irinotecan
干预措施: Irinotecan (Drug)
FOLFIRI
Placebo Comparator
5-fluorouracil,folinate combined with irinotecan
干预措施: 5-fluorouracil (Drug)
FOLFIRI
Placebo Comparator
5-fluorouracil,folinate combined with irinotecan
干预措施: Leucovorin (Drug)
结局指标
主要结局
progression free survival
时间窗: 2 months
次要结局
- overall survival(6 months)
- overall response rate(2 months)
- disease control rate(2 months)
- Number of Participants with Adverse Events(2 months)
- quality of life questionnaire(2 months)
研究者
Jin Li
Fudan University Shanghai Cancer Center
Fudan University
研究点 (1)
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