NCT01472770已完成2 期
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Rate of patients progression free at 3 months
研究概览
简要总结
The present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified colorectal adenocarcinomas
- •Age > 18 years
- •Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents.
- •Measurable disease according to RECIST 1.1
- •ECOG performance status 0, 1 or 2
- •Adequate renal, hepatic and haematological function
- •Consent to blood samples and available paraffin embedded tumour material for translational research studies
- •Fertile males and females (<2 years after last period for women) must use effective birth control.
- •Signed Informed consent
排除标准
- •Clinically significant concurrent disease.
- •Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
- •Other experimental therapy within 30 days of treatment initiation.
- •Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception.
- •Clinical or radiological evidence of CNS metastasis.
- •Planned radiation therapy against target-lesions.
- •Known allergy to 5FU/capecitabine or gemcitabine.
结局指标
主要结局
Rate of patients progression free at 3 months
时间窗: 3 months after start of treatment
次要结局
- Overall survival(Every 12 weeks)
- Progression free survival(Every 12 weeks)
研究者
研究点 (2)
Loading locations...
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