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Efficacy of Imatinib and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct

2014-08-27 03:12:31 | BioPortfolio

Summary

To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or metastatic cholangiocellular carcinoma.

Description

Efficacy: Tumor assessments should be performed by a CT or MRI scan, throughout the study. All assessments should be performed within 14 days of the scheduled day according to the visit schedules, and whenever clinically indicated otherwise. Radiological studies must use the same techniques as used at baseline. Evaluation will be based on RECIST criteria.

Safety: Safety assessments will consist of evaluating adverse events and serious adverse events, laboratory parameters including hematology, chemistry, vital signs, physical examinations, and documentation of all concomitant medications and/or therapies.

Study Design

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

Conditions

Advanced or Metastatic Cholangiocellular Carcinoma and Bile Duct

Intervention

Glivec

Location

Krankenhaus Nordwest
Frankfurt/ Main
Hessen
Germany
60488

Status

Completed

Source

University Hospital Dresden

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:31-0400

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