Evidence map›Paper›PMID 39427654›Full record

Trial reportOncology2025

Tissue and Imaging Biomarkers of Response to Neoadjuvant Nivolumab or Nivolumab plus Ipilimumab in Patients with Resectable Hepatocellular Carcinoma.

Michael LaPelusa, Shadi Chamseddine, Hop Sanderson Tran Cao, Lianchun Xiao, Elshad Hasanov, Priya Bhosale, Hesham M Amin, Yehia I Mohamed, Betul Gok Yavuz, Yara Sakr and 13 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03222076 (An Open-Label Preoperative Pilot Study Evaluating Nivolumab), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT03222076 phase2completednot on this map

An Open-Label Preoperative Pilot Study Evaluating Nivolumab (Anti-PD-1 Antibody) Alone Versus Nivolumab Plus Ipilimumab (Anti-CTLA-4 Antibody) in Patients With Resectable (HCC)

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2017 to 2022Enrolled30ConditionsHepatocellular Carcinoma, Resectable Hepatocellular CarcinomaArmsIpilimumab, Nivolumab
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
  5. 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

23 authors.

Michael LaPelusaDivision of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA, mblapelusa@mdanderson.org.
Shadi ChamseddineDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Hop Sanderson Tran CaoDepartment of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Lianchun XiaoDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Elshad HasanovThe Ohio State University Comprehensive Cancer Center - The James, Columbus, Ohio, USA.
Priya BhosaleDepartment of Abdominal Imaging, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Hesham M AminDepartment of Hematopathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Yehia I MohamedDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Betul Gok YavuzUniversity of Missouri School of Medicine, Columbia, Missouri, USA.
Yara SakrDepartment of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Li XuDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Ian HuDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Sunyoung S LeeDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Divya SakamuriDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Sonali JindalThe Immunotherapy Platform, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Van NguyenDepartment of Pharmacy Clinical Programs, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Michael A CurranDepartment of Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Ryan SunDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Asif RashidDepartment of Anatomic Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Dan Gabriel DudaSteele Laboratories, Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts, USA.
Padmanee SharmaDepartment of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Aliya QayyumDepartment of Imaging and Interventional Radiology, Moffitt Cancer Center, Tampa, Florida, USA.
Ahmed Omar KasebDepartment of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
The University of Texas MD Anderson Cancer Center SPORE in Hepatocellular CarcinomaP50CA217674 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI YAO, JAMES C · 2019 to 2023
$11.3M
A Phase II and Biomarker Study of Dual VEGF/PD-L1 Blockade in Neoadjuvant Setting in Resectable HCC PatientsR01CA260872 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI AMIN, HESHAM M, DUDA, DAN GABRIEL · 2021 to 2025
$3.0M
NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA217674NCI NIH HHS R01 CA260872
6 · The paper itself

Abstract

introductionPerioperative immunotherapy has shown promise in some patients with early-stage hepatocellular carcinoma (HCC). This study examined tissue and imaging biomarkers associated with pathologic response in a phase II clinical trial in patients with resectable HCC.

methodsAnalysis included 18 patients with biopsy-proven resectable HCC treated with neoadjuvant nivolumab plus ipilimumab or nivolumab alone in a phase II clinical trial at MD Anderson Cancer Center (NCT03222076). Liver MRE (to measure tissue fibrosis) and biopsies (to evaluate immune activation markers) were obtained serially pretreatment and after completing neoadjuvant immunotherapy. A major pathologic response (MPR) was defined as tumor necrosis of more than 70%. Data comparing patients with MPR versus those without were summarized using descriptive statistics and compared using the Wilcoxon rank-sum test.

resultsPatients with MPR after neoadjuvant immunotherapy tended to have larger tumors (mean 9.52 vs. 4.99 centimeters; p = 0.050). They had a significant reduction in tumor size posttreatment (14.67% reduction vs. 9.15% increase in size; p = 0.042) and a nonsignificant decrease in serum AFP (-24.20% vs. -14.00%; p = 0.085). Further, patients with MPR had a greater increase in intratumoral expression levels of CD8 (26.92% vs. -0.04%; p = 0.026), granzyme B (15.56% vs. -2.24%; p = 0.011), and PD-1 (20.17% vs. 0.40%; p = 0.048) but not PD-L1 (7.69% vs. 0.57%; p = 0.26). For imaging biomarkers, tumor and liver fibrosis were comparable before and after neoadjuvant therapy in patients with MPR versus nonresponders.

conclusionChanges in tumor size, immune cell infiltration, and immune cell activation are candidate predictive markers of pathologic response to neoadjuvant immunotherapy in patients with resectable HCC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularIpilimumabLiver NeoplasmsNivolumabAdultAgedBiomarkers, TumorFemaleHumansMaleMiddle AgedNeoadjuvant TherapyTreatment OutcomeBiomarkers, TumorIpilimumabNivolumabHepatocellular carcinomaNeoadjuvant immunotherapy

Identifiers

PMID39427654
PMCPMC12006443

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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.