Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
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