Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

Cholangiocellular Carcinoma Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01073839
Study type	Interventional
Source	University of Zurich
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 2008
Completion date	August 2015

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