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The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter study

Not Applicable
Recruiting
Conditions
biliary tract cancer
Registration Number
JPRN-UMIN000012983
Lead Sponsor
Kawasaki Medical School
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
25
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with an active concomitant malignancy 2) Patients with a previous history of a severe drug hypersensitivity 3) Patients with severe comobidities (pulmonary fibrosis or interstitial pneumonia, cardiovascular failure, renal failure, hepatic failure, hemorrhagic digestive ulcer, and gastrointestinal bleeding, intestinal tract paralysis, ileus, uncontrollable diabetes ). 4) Patients with an active concomitant infection 5) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 6) Patients with a severe mental disorder 7) Inappropriate patients for entry on this study in the judgement of the investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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