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

Sponsor
Zhejiang University
Study ID
NCT02558959
Phase
PHASE2
Status
Completed

Conditions

  • Biliary Tract Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 1, 2015
Status verified
Feb 2018
Primary completion
Sep 30, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan and Capecitabine
    irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w
  • Active Comparator: Irinotecan
    irinotecan 180mg/m2 d1, q2w

Primary Outcome Measure

Progression Free Survival [ Time Frame: within 1 year ]

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