Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer

Phase 2

Completed

• Conditions: Biliary Tract Neoplasms
• Interventions: Drug: Irinotecan; Drug: Capecitabine

• Registration Number: NCT02558959
• Lead Sponsor: Zhejiang University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Primary Completion: 2017-09-30
• Study Completion: 2017-12-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-10
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irinotecan and Capecitabine	Irinotecan	irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w
Irinotecan and Capecitabine	Capecitabine	irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w
Irinotecan	Irinotecan	irinotecan 180mg/m2 d1, q2w

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	within 1 year	PFS

Secondary Outcome Measures

Name	Time	Method
Overall Survival	within 1 year	OS

Trial Locations

Locations (1)

First affiliated hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China