Spots Global Cancer Trial Database for Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

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Trial Identification

Brief Title: Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

Official Title: Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.

Study ID: NCT01073839

Conditions

Cholangiocellular Carcinoma

Interventions

Cisplatin and Gemcitabine

Study Description

Brief 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

Detailed Description: