Evidence map›Paper›PMID 40728861›Full record

ArticleFuture oncology (London, England)2025

ABC-12: exploring the microbiome in patients with advanced biliary tract cancer in a first-line study of durvalumab (MEDI4736) in combination with cisplatin/gemcitabine.

Eleni Vrana, Hayley Timmins, Ashley Osborne, Rebecca Cox, Harpreet Wasan, Yuk Ting Ma, Arvind Arora, Olusola Faluyi, Roopinder Gillmore, Pippa Corrie and 14 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Future oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

24 authors.

Eleni VranaDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Hayley TimminsCentre for Trials Research, Cardiff University, Wales, UK.
Ashley OsborneDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Rebecca CoxDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Harpreet WasanHammersmith Hospital, Imperial College, London, UK.
Yuk Ting MaUniversity Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Arvind AroraUniversity Hospital of Nottingham, Nottingham, UK.
Olusola FaluyiClatterbridge Cancer Centre, Liverpool, UK.
Roopinder GillmoreRoyal Free Hospital, London, UK.
Pippa CorrieAddenbrooke's Hospital, Cambridge, UK.
Paul MillerChurchill Hospital, Oxford, UK.
Seema ArifVelindre Cancer Centre, Cardiff Wales, UK.
Joanna CanhamCentre for Trials Research, Cardiff University, Wales, UK.
Charlotte MartinCentre for Trials Research, Cardiff University, Wales, UK.
Muhammad RiazCentre for Trials Research, Cardiff University, Wales, UK.
Tongtong ShiCentre for Trials Research, Cardiff University, Wales, UK.
Melissa FrizzieroDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Victoria FoyDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Richard A HubnerDepartment of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
Helen MorementAMMF - The Cholangiocarcinoma Charity, UK.
John BridgewaterUniversity College London Cancer Institute, London, UK.
Richard AdamsCentre for Trials Research, Cardiff University, Wales, UK.
Juan W ValleThe Cholangiocarcinoma Foundation, Utah, USA.
Mairéad G McNamaraDivision of Cancer Sciences, Department of Medical Oncology, University of Manchester, The Christie NHS Foundation Trust, Manchester, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Until recently, cisplatin/gemcitabine was standard of care for the first-line treatment of patients with advanced biliary tract cancer (BTC). The addition of durvalumab, an immune checkpoint inhibitor, to the combination of cisplatin/gemcitabine has demonstrated an overall survival (OS) benefit and is now a standard of care first-line treatment option. BTCs exhibit immunogenic features may develop through an accumulation of genetic and epigenetic alterations, and can be influenced by microbial exposure. Microbiota can influence inflammation and immunity, and its disruption may impair tumor response to immunotherapy and chemotherapy. Here, the rationale and design of the multi-center, single-arm ABC-12 trial (ISRCTN11210442) is described, which investigates the role of the microbiome in patients with advanced BTC in a first-line study of durvalumab (MEDI4736) in combination with cisplatin/gemcitabine. The primary objective is to determine the difference in baseline alpha diversity between "responders" (partial or complete response) and "non-responders" at 18 weeks (RECIST 1.1) in patients treated with cisplatin/gemcitabine/durvalumab. Secondary objectives include investigating the association between microbiome parameters and objective response rate, tumor control (partial, complete response, and stable disease), progression-free and OS, and investigating the interaction between treatment effect and microbiome parameters on clinical outcomes.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsGastrointestinal MicrobiomeAntibodies, MonoclonalCisplatinDeoxycytidineFemaleGemcitabineHumansMulticenter Studies as TopicTreatment OutcomeAntibodies, MonoclonalCisplatinDeoxycytidinedurvalumabGemcitabineAdvanced biliary tract cancercisplatindurvalumabfirst-line treatmentgemcitabinemicrobiome

Identifiers

PMID40728861
PMCPMC12407636

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.