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Adjuvant Gemcitabine in Operable Cholangiocellular Carcinoma.

2014-08-27 03:15:42 | BioPortfolio

Summary

OBJECTIVES

Primary objective:

The primary objective of the trial is to determine the safety of adjuvant treatment with 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

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cholangiocellular Carcinoma

Intervention

Gemcitabine

Location

Zurich
Switzerland

Status

Recruiting

Source

University of Zurich

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:42-0400

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