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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2017-12-31

Brief Summary

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This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.

Detailed Description

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Conditions

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Biliary Tract Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Irinotecan and Capecitabine

irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

Irinotecan

irinotecan 180mg/m2 d1, q2w

Group Type ACTIVE_COMPARATOR

Irinotecan

Intervention Type DRUG

Interventions

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Irinotecan

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin
* 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

* The presence of any severe concomitant disease that could interrupt the planned treatment
* Intractable pain
* Hypersensitivity to study drugs
* Serious cardiovascular disease
* If female, pregnancy or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Weijia Fang

Director of Cancer Biotherapy Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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ZYYYMedOncoBIL01

Identifier Type: -

Identifier Source: org_study_id

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