NCT01073839

Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cholangiocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin and Gemcitabine	Cisplatin 25 mg/m2 days 1 and 8; next cycle starting day 22. Gemcitabine 1000 mg/m2 days 1 and 8; next cycle starting day 22. Total of 8 cycles.

Timeline

• Start date: 2008-08-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2010-02-23
• Last updated: 2015-09-18

Locations

1 site across 1 country: Switzerland