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

Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02558959

Enrollment

Registered

2015-09-24

Start date

2015-09-01

Completion date

2017-12-31

Last updated

2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Neoplasms

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.

Interventions

DRUGIrinotecan

DRUGCapecitabine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Progression Free Survival	within 1 year	PFS

Secondary

Measure	Time frame	Description
Overall Survival	within 1 year	OS

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026