Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0
研究概览
简要总结
OBJECTIVES
Primary objective:
The primary objective of the trial is to determine the safety of adjuvant treatment with cisplatin plus gemcitabine for a period of 6 months after curative resection of cholangiocellular carcinoma
Secondary objectives:
Secondary objectives of the trial are to assess the feasibility and efficacy of the adjuvant therapy and to determine duration of response and patterns of failure compared to historical controls without postoperative treatment
Exploratory objectives:
To obtain blood samples and tumor tissue after resection for establishment and characterization of new cholangiocarcinoma cell lines and tumor antigens. Other aims are identification of tumor specific antibodies from blood samples, and characterization of tumor antigens with consecutive development of new specific immunological therapies, e.g. cancer-testis antigens (CTA) for tumor vaccination.
- Trial with medicinal product
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cisplatin plus Gemcitabine
Patients after resection of cholangiocellular carcinoma will be allocated to treatment with cisplatin plus gemcitabine.
干预措施: Cisplatin and Gemcitabine (Drug)
结局指标
主要结局
Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0
时间窗: One year
次要结局
- Disease-free survival(5 years)
研究者
Bernhard Pestalozzi
Prof. Dr. med.
University of Zurich