Evidence map›Paper›PMID 39965889›Full record

Trial reportGut2025

Multiomics analysis of immune correlatives in hepatocellular carcinoma patients treated with tremelimumab plus durvalumab.

Yuta Myojin, Sepideh Babaei, Rajiv Trehan, Christoph Hoffman, Noemi Kedei, Benjamin Ruf, Mohamed-Reda Benmebarek, Kylynda C Bauer, Patrick Huang, Chi Ma and 28 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gut, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02821754 (A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

NCT02821754 phase2completednot on this map

A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2016 to 2022Enrolled54ConditionsBiliary Tract Neoplasms, Liver Cancer, Hepatocellular Carcinoma, CholangiocarcinomaArmsDurvalumab, Tremelimumab, Trans-arterial Catheter Chemoembolization (TACE), Radiofrequency Ablation (RFA), Cryoablation
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. IL-1 family of cytokines in gastrointestinal and liver disorders.Nature reviews. Gastroenterology & hepatology · 2026
    Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Spatial immune scoring and prediction of HCC outcomes.JHEP reports : innovation in hepatology · 2025
    Article
  13. Review
  14. Article
  15. Article
  16. Heterogeneity of monocytes in cancer.American journal of cancer research · 2025
    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

38 authors.

Yuta MyojinGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0003-0360-9703
Sepideh BabaeiInterfaculty Institute for Biomedical Informatics (IBMI), University of Tübingen, Tubingen, Germany.
Rajiv TrehanGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Christoph HoffmanInterfaculty Institute for Biomedical Informatics (IBMI), University of Tübingen, Tubingen, Germany.
Noemi KedeiCollaborative Protein Technology Resources, Office of Science and Technology Resources, National Institutes of Health, Bethesda, Maryland, USA.
Benjamin RufGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Mohamed-Reda BenmebarekGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Kylynda C BauerGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Patrick HuangGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Chi MaGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0002-4171-0813
Cecilia MongeGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Changqing XieGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Donna HronesGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Austin G DuffyMater Misericordiae University Hospital, Dublin, Ireland.
Paul ArmstrongMater Misericordiae University Hospital, Dublin, Ireland.
Lorenz KocheiseGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Fiona DesmondMater Misericordiae University Hospital, Dublin, Ireland.
Jemma BuchalterMater Misericordiae University Hospital, Dublin, Ireland.
Marie GalliganClinical Research Centre, University College Dublin, Dublin, Ireland.
Colin CantwellSt Vincent's University Hospital, University College Dublin, Dublin, Ireland.
Ronan RyanSt Vincent's University Hospital, University College Dublin, Dublin, Ireland.
Jeff McCannSt Vincent's University Hospital, University College Dublin, Dublin, Ireland.
Michele BourkeSt Vincent's University Hospital, University College Dublin, Dublin, Ireland.
Ross Mac NicholasSt Vincent's University Hospital, University College Dublin, Dublin, Ireland.
Ray McDermottSt Vincent's University Hospital, University College Dublin, Dublin, Ireland.
Joy AwosikaGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Maggie CamCenter for Collaborative Bioinformatics, National Institutes of Health, Bethesda, Maryland, USA.
Rosanna KrebsInterfaculty Institute for Biomedical Informatics (IBMI), University of Tübingen, Tubingen, Germany.
Anuradha BudhuLaboratory of Human Carcinogenesis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Mahler RevsineLaboratory of Human Carcinogenesis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
William D FiggGenitourinary Malignancies Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
David E KleinerLiver Cancer Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0003-3442-4453
Bernadette ReddRadiology and Imaging Sciences, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Bradford J WoodLiver Cancer Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Xin Wei WangLaboratory of Human Carcinogenesis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Firouzeh KorangyGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0002-0712-1409
Manfred ClaassenInterfaculty Institute for Biomedical Informatics (IBMI), University of Tübingen, Tubingen, Germany.
Tim F GretenGastrointestinal Malignancies Section, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA tim.greten@nih.gov.ORCID http://orcid.org/0000-0002-0806-2535

Funding

Sample Processing and Analytical Methods Development for New Anticancer AgentsZICSC006536 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$18.1M
Liver Cancer ProgramZIABC011870 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WANG, XIN WEI · 2019 to 2025
$10.1M
Clinical protocols for the treatment of GI cancerZIABC011343 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GRETEN, TIM · 2010 to 2025
$4.8M
Intramural NIH HHS ZIA BC011343Intramural NIH HHS ZIA BC011870Intramural NIH HHS ZIC SC006536
6 · The paper itself

Abstract

backgroundHepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality. The combination of tremelimumab and durvalumab is now a standard treatment option for advanced HCC.

objectiveTo study immune responses in HCC patients treated with tremelimumab and durvalumab.

designWe treated 28 HCC patients with durvalumab, tremelimumab and locoregional therapies. We performed a high-dimensional multiomics analysis including whole exome sequencing, single-cell RNA seq, CO-Detection by indEXing, flow cytometry and multiplex cytokine/chemokine analysis of patients' blood and tumour samples and integrated this data to elucidate immune correlatives and response mechanisms. Mice with syngeneic HCC were treated with anti-PD-L1 plus anti-CTLA4 for hepatic lymphocytes, tumour-infiltrating lymphocytes and peripheral blood mononuclear cell analysis.

resultsThe median overall survival was 19.2 months. Tumour tissue analysis revealed enhanced interferon responses, with stronger effects in responders. Gene set variation analysis indicated enhanced antigen presentation in responders. Spatial analysis revealed that non-responder tumours had higher numbers of Tregs located in neighbourhoods enriched with immune cells and expressed higher levels of ICOS and PD-1. Conversely, non-responder PD1+CD8+T in these Treg-enriched neighbourhoods expressed lower ICOS. Cell-communication analysis demonstrated that Treg-CD8+T interaction was enhanced in non-responder tissue. Peripheral blood analysis showed increased classical monocytes in responders and Tregs in non-responders. Treg-CD8+T interaction was confirmed in preclinical models. Finally, single-patient computational analysis from the all-across analysis was performed on 860 features, which led to the identification of multiomics feature sets including Treg features.

conclusionOur study provides a blueprint for in-depth analysis of immune correlates in immunotherapy studies and demonstrates the importance of Treg distribution in HCC. TRIAL REGISTRATION NUMBERS: NCT02821754 and the EudraCT identifier: 2019-002767-98.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularLiver NeoplasmsAgedAnimalsAntibodies, MonoclonalFemaleHumansLymphocytes, Tumor-InfiltratingMaleMiceMiddle AgedMultiomicsT-Lymphocytes, RegulatoryAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddurvalumabtremelimumabCLINICAL TRIALSHEPATOCELLULAR CARCINOMAIMMUNOTHERAPY

Identifiers

PMID39965889
PMCPMC12392412

What Socratic holds

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Registered trials

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 Socratic graph.