Evidence map›Paper›PMID 29955136›Full record

Trial reportBritish journal of cancer2018

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

Yi Zheng, Xiaoxuan Tu, Peng Zhao, Weiqin Jiang, Lulu Liu, Zhou Tong, Hangyu Zhang, Cong Yan, Weijia Fang, Weilin Wang

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. SEOM-GEMCAD-TTD clinical guidelines for biliary tract cancer (2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Guideline
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  10. Digestive cancers: mechanisms, therapeutics and management.Signal transduction and targeted therapy · 2025
    Review
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  18. Systemic Treatment for Cholangiocarcinoma.Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer · 2023
    Article
  19. Expert consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology on the determination of biomarkers in pancreatic and biliary tract cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022
    Article
  20. Gallbladder cancer.Nature reviews. Disease primers · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Yi ZhengCancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Xiaoxuan TuCancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Peng ZhaoCancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Weiqin JiangCancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Lulu LiuCancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Zhou TongCancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Hangyu ZhangCancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Cong YanCancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Weijia FangCancer Biotherapy Centre, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Weilin WangDepartment of Hepatobiliary Pancreatic Surgery, the First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China. wam@zju.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsSixty-four GP refractory ABTC patients were randomised to either irinotecan 180 mg/m

resultsA 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.

conclusionsThis 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.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsCapecitabineCisplatinDeoxycytidineDrug-Related Side Effects and Adverse ReactionsFemaleGemcitabineHumansIrinotecanMaleMiddle AgedTreatment OutcomeCapecitabineCisplatinDeoxycytidineGemcitabineIrinotecan

Identifiers

PMID29955136
PMCPMC6068158

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.