Evidence map›Paper›PMID 38325328›Full record

Trial reportThe oncologist2024

A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma.

Shawn Yu, Menggang Yu, Barry Keane, David M Mauro, Paul R Helft, William P Harris, Hanna K Sanoff, Matthew S Johnson, Bert O'Neil, Autumn Jackson McRee and 1 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03099564 (A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma With Preserved Liver Function. HCRN), which is not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
12.6field-weighted citation impact, top 1% of its field
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.

NCT03099564 early_phase1unknown statusnot on this map

A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma With Preserved Liver Function. HCRN: GI15-225

TypeinterventionalSponsorAshwin SomasundaramRan2017 to 2023Enrolled30ConditionsHepatocellular CarcinomaArmsPembrolizumab, Y90 radioembolization
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
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  3. Journal of gastrointestinal cancer · 2025
    Pooled it
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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

11 authors at 7 institutions in 1 country.

Shawn YuDepartment of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Menggang YuDepartment of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
Barry KeaneDepartment of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
David M MauroDepartment of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Paul R HelftDepartment of Medicine, Indiana University Simon Cancer Center, Indianapolis, IN, USA.
William P HarrisDepartment of Medicine, University of Washington/FHCC, Seattle, WA, USA.
Hanna K SanoffDepartment of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Matthew S JohnsonDepartment of Radiology and Imaging Sciences, Indiana University, Indianapolis, IN, USA.
Bert O'NeilCommunity Health Network, Indianapolis, IN, USA.
Autumn Jackson McReeJanssen Research & Development, LLC, Spring House, PA, USA.
Ashwin SomasundaramDepartment of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0003-3167-406X
University of North Carolina at Chapel Hill · USCommunity Health Network · USIndiana University Health · USIndiana University – Purdue University Indianapolis · USJanssen (United States) · USUniversity of Michigan · USUniversity of Washington · US

Funding

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
The role of IL6-induced LAG3 as a resistance mechanism to PD1 blockade in NSCLC patientsK08CA259342 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Ashwin Somasundaram · 2023 to 2026
$1.1M
NCI NIH HHS K08 CA259342NIGMS NIH HHS T32 GM086330
6 · The paper itself

Abstract

backgroundCombination checkpoint inhibition therapy with yttrium-90 (Y90) radioembolization represents an emerging area of interest in the treatment of advanced hepatocellular carcinoma (HCC). HCRN GI15-225 is an open-label, single-arm multicenter, pilot study (NCT03099564).

methodsEligible patients had poor prognosis, localized HCC defined as having portal vein thrombus, multifocal disease, and/or diffuse disease that were not eligible for liver transplant or surgical resection. Patients received pembrolizumab 200 mg intravenously every 3 weeks in conjunction with glass yttrium-90 (Y90) radioembolization TheraSphere. Primary endpoint was 6-month progression-free survival (PFS6) per RECIST 1.1. Secondary endpoints included time to progression (TTP), objective response rate (ORR), overall survival (OS), and safety/tolerability.

resultsBetween October 23, 2017 and November 24, 2020, 29 patients were enrolled: 2 were excluded per protocol. Fifteen of the remaining 27 patients were free of progression at 6 months (55.6%; 95% CI, 35.3-74.5) with median PFS 9.95 months (95% CI, 4.14-15.24) and OS 27.30 months (95% CI, 10.15-39.52). One patient was not evaluable for response due to death; among the remaining 26 patients, ORR was 30.8% (95% CI, 14.3-51.8) and DCR was 84.6% (95% CI, 65.1-95.6).

conclusionIn patients with localized, poor prognosis HCC, pembrolizumab in addition to glass Y90 radioembolization demonstrated promising efficacy and safety consistent with prior observations (ClinicalTrials.gov Identifier: NCT03099564; IRB Approved: 16-3255 approved July 12, 2016).

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, HepatocellularLiver NeoplasmsYttrium RadioisotopesHumansPilot ProjectsProgression-Free SurvivalTreatment OutcomeAntibodies, Monoclonal, HumanizedpembrolizumabYttrium-90Yttrium Radioisotopesglass Y90 radioembolizationhepatocellular carcinomaimmunotherapypembrolizumabTARE

Identifiers

PMID38325328
PMCPMC10911903
OpenAlexW4391650970

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.