NCT01348256Unknown2 期
Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
Clinica Universidad de Navarra, Universidad de Navarra2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Progression Free survival
研究概览
简要总结
In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.
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
- •Age over 18 years.
- •Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.
- •Capacity of understanding and signing the informed consent and to undergo the study procedures
- •Availability of tumor tissue, for maturing dendritic cells
- •Adequate renal, hepatic and bone marrow function
排除标准
- •Clinically relevant diseases or infections.
- •Concurrent participation in other clinical trial or administration or other antitumoral treatment
- •Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
- •Pregnant or breast feeding women
- •Immunosuppressant treatment
研究组 & 干预措施
Dendritic cells vaccine
Experimental
Adjuvant treatment with dendritic cells vaccine after standard treatment
干预措施: Dendritic cells vaccine (Drug)
结局指标
主要结局
Progression Free survival
时间窗: Progression free survival at 2 years
次要结局
- Overall survival(2 years)
研究者
研究点 (2)
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