Advanced or Metastatic Cholangiocellular Carcinoma and Bile Duct Clinical Trial
Official title:
Phase II Study to Evaluate the Efficacy of a Chemotherapy Combination With Imatinib (Glivec®) and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct
To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or metastatic cholangiocellular carcinoma.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment