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Clinical Study

A randomised phase II study of second-line XELIRI regimen versus irinotecan monotherapy in advanced biliary tract cancer patients progressed on gemcitabine and cisplatin

British Journal of Cancer (2018) | Download Citation



The majority of advanced biliary tract cancer (ABTC) patients will progress after gemcitabine and cisplatin (GP) doublet therapy, while the standard second-line regimen has not been established. We conducted this study to assess the efficacy and safety of second-line irinotecan and capecitabine (XELIRI) regimen vs. irinotecan monotherapy in ABTC patients progressed on GP.


Sixty-four GP refractory ABTC patients were randomised to either irinotecan 180 mg/m2 on day 1 plus capecitabine 1000 mg/m2 twice daily on days 1–10 of a 14-day cycle (XELIRI-arm) or single-agent irinotecan 180 mg/m2 on day 1 of a 14-day cycle (IRI-arm). Treatments were repeated until disease progression or unacceptable toxicity occurred.


A total of 60 patients were included in the analysis. For XELIRI and IRI-arms, respectively, the median PFS was 3.7 vs. 2.4 months, 9-month survival rate 60.9% vs. 32.0%, median OS 10.1 vs. 7.3 months, and disease control rate 63.3% vs. 50.0%. The most common grade 3 or 4 toxicities were leucopaenia and neutropaenia.


This randomised, phase II study of irinotecan-containing regimens in good PS second-line ABTC patients showed a clear benefit of XELIRI regimen over irinotecan monotherapy in prolonging PFS, with acceptable toxicity.

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This work was supported by grants from National Natural Science Foundation of China (81472346)

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Author notes

  1. These authors contributed equally: Yi Zheng, Xiaoxuan Tu.


  1. Cancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China

    • Yi Zheng
    • , Xiaoxuan Tu
    • , Peng Zhao
    • , Weiqin Jiang
    • , Lulu Liu
    • , Zhou Tong
    • , Hangyu Zhang
    • , Cong Yan
    •  & Weijia Fang
  2. Department of Hepatobiliary Pancreatic Surgery, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China

    • Weilin Wang


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W.W. and W.F. designed the study, guided data analysis and interpretation and revised the manuscript critically for important intellectual content. Y.Z., X.T., P.Z., W.J., L.L., Z.T. and H.Z. conducted the clinical trial. Y.Z. and X.T. collected clinical and pathological information from the cancer patients, analysed data and wrote the manuscript. All authors reviewed the manuscript.

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The authors declare no competing interests.

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This work is published under the standard license to publish agreement. After 12 months the work will become freely available and the license terms will switch to a Creative Commons Attribution 4.0 International (CC BY 4.0).

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Correspondence to Weilin Wang.

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