Evidence map›Paper›PMID 40317333›Full record

Observational studyCancer immunology, immunotherapy : CII2025

Transcriptomic and proteomic characterization of cell and protein biomarkers of checkpoint inhibitor-induced liver injury.

Changhua Ji, Steven Kumpf, Jessie Qian, Joel D Federspiel, Mark Sheehan, Darien Capunitan, Edmond Atallah, Stuart Astbury, Seda Arat, Elias Oziolor and 5 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Cancer immunology, immunotherapy : CII, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04476563 (Checkpoint Inhibitor-induced Liver Injury Study), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT04476563 recruitingnot on this map

Checkpoint Inhibitor-induced Liver Injury Study (ChILI)

TypeobservationalSponsorUniversity of NottinghamRan2020 to 2026Enrolled160ConditionsImmune-Mediated HepatitisArmsObtaining biological samples
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Macrophage-CD8medRxiv : the preprint server for health sciences · 2026
    Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
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

15 authors.

Changhua JiDrug Safety R&D, Pfizer Inc, 10777 Science Center Dr., La Jolla, CA, 92121, USA. jichanghua5@gmail.com.
Steven KumpfDrug Safety R&D, Pfizer Inc, Eastern Point Rd, 274-3715A, Groton, CT, 06340, USA.
Jessie QianDrug Safety R&D, Pfizer Inc, Eastern Point Rd, 274-3715A, Groton, CT, 06340, USA.
Joel D FederspielDrug Safety R&D, Pfizer, Andover, MA, USA.
Mark SheehanDrug Safety R&D, Pfizer Inc, Eastern Point Rd, 274-3715A, Groton, CT, 06340, USA.
Darien CapunitanDrug Safety R&D, Pfizer Inc, Eastern Point Rd, 274-3715A, Groton, CT, 06340, USA.
Edmond AtallahNottingham Digestive Diseases Centre, Translational Medical Sciences, School of Medicine, University of Nottingham, Nottingham, UK.
Stuart AstburyNottingham Digestive Diseases Centre, Translational Medical Sciences, School of Medicine, University of Nottingham, Nottingham, UK.
Seda AratDrug Safety R&D, Pfizer Inc, Eastern Point Rd, 274-3715A, Groton, CT, 06340, USA.
Elias OziolorDrug Safety R&D, Pfizer Inc, Eastern Point Rd, 274-3715A, Groton, CT, 06340, USA.
Mireia Fernandez OcanaDrug Safety R&D, Pfizer, Andover, MA, USA.
Shashi K RamaiahDrug Safety R&D, Pfizer, Cambridge, MA, USA.
Jane GroveNottingham Digestive Diseases Centre, Translational Medical Sciences, School of Medicine, University of Nottingham, Nottingham, UK.
Guruprasad P Aithal *Nottingham Digestive Diseases Centre, Translational Medical Sciences, School of Medicine, University of Nottingham, Nottingham, UK.
Thomas A Lanz *Drug Safety R&D, Pfizer Inc, Eastern Point Rd, 274-3715A, Groton, CT, 06340, USA. thomas.a.lanz@pfizer.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Immune checkpoint inhibitors (ICI) targeting CTLA-4 and PD-1 have shown remarkable antitumor efficacy, but can also cause immune-related adverse events, including checkpoint inhibitor-induced liver injury (ChILI). This multi-omic study aimed to investigate changes in blood samples from treated cancer patients who developed ChILI. PBMCs were sequenced for by transcriptomic and T cell receptor repertoire (bulk and single-cell immune profiling), and extracellular vesicle (EV) enrichment from plasma was analyzed by mass spectroscopy proteomics. Data were analyzed by comparing the ChILI patient group to the control group who did not develop ChILI and by comparing the onset of ChILI to pre-ICI treatment baseline. We identified significant changes in T cell clonality, gene expression, and proteins in peripheral blood mononuclear cells (PBMCs) and plasma in response to liver injury. Onset of ChILI was accompanied by an increase in T cell clonality. Pathway analysis highlighted the involvement of innate and cellular immune responses, mitosis, pyroptosis, and oxidative stress. Single-cell RNA sequencing revealed that these changes were primarily found in select T cell subtypes (including CD8 + effector memory cells), while CD16 + monocytes exhibited enrichment in metabolic pathways. Proteomic analysis of plasma extracellular vesicles showed enrichment in liver-associated proteins among differentially expressed proteins. Interestingly, an increase in PBMC PD-L1 gene expression and plasma PD-L1 protein was also found to be associated with ChILI onset. These findings provide valuable insights into the immune and molecular mechanisms underlying ChILI as well as potential biomarkers of ChILI.Trial registration number NCT04476563.

Indexed as

BiomarkersChemical and Drug Induced Liver InjuryImmune Checkpoint InhibitorsNeoplasmsProteomicsTranscriptomeAgedFemaleHumansLeukocytes, MononuclearMaleMiddle AgedBiomarkersImmune Checkpoint InhibitorsBiomarkerCheckpoint inhibitorChILILiver injuryPD-L1

Identifiers

PMID40317333
PMCPMC12049347

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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 OpenQuestion graph.