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OpenTrials
Completed

NCT Number: NCT02558959

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

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.

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Key information

Conditions

Biliary Tract Neoplasms Biliary Tract Diseases Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irinotecan

Drug

Capecitabine

Drug

Primary outcomes

  1. Progression Free Survival

    Time frame: within 1 year

    PFS

Secondary outcomes

  1. Overall Survival

    Time frame: within 1 year

    OS

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2015
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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