Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer
NCT ID: NCT02558959
Last Updated: 2018-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2015-09-01
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Irinotecan and Capecitabine
irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w
Irinotecan
Capecitabine
Irinotecan
irinotecan 180mg/m2 d1, q2w
Irinotecan
Interventions
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Irinotecan
Capecitabine
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
* Karnofsky performance status (KPS) of at least 70%
* Adequate renal function, adequate hepatic function, adequate bone marrow function
Exclusion Criteria
* Intractable pain
* Hypersensitivity to study drugs
* Serious cardiovascular disease
* If female, pregnancy or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
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Zhejiang University
OTHER
Responsible Party
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Weijia Fang
Director of Cancer Biotherapy Center
Locations
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First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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ZYYYMedOncoBIL01
Identifier Type: -
Identifier Source: org_study_id
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