Evidence map›Paper›PMID 41937811›Full record

ArticleJCO oncology advances2026

Tumor-Targeted IL-12 (PDS01ADC) with Hepatic Artery Infusion Pump Therapy for Colorectal Liver Metastases: Interim Analysis of a Non-randomized Phase II Trial.

Alyssa V Eade, Emily C Smith, Cecilia Monge, Cathleen E Hannah, Nebojsa Skorupan, Donna M Hrones, Carolina Celades, Meghali Goswami, Hana Bagheri, Kathleen M Smith and 22 more

Registry-linked trialAbstract read
In one paragraph

Article in JCO oncology advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05286814 (Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump), which is not on this 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.

NCT05286814 phase2recruitingnot on this map

Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2022 to 2028Enrolled70ConditionsMetastatic Colorectal Cancer (Mcrc), Intrahepatic Cholangiocarcinoma (Icc), Intrahepatic Bile Duct Cancer, Colorectal NeoplasmsArmsDexamethasone, PDS01ADC, Intera 3000 Hepatic Artery Infusion Pump (HAIP), Floxuridine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

32 authors.

Alyssa V EadeSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Emily C SmithSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Cecilia MongeThoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Cathleen E HannahSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Nebojsa SkorupanThoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Donna M HronesThoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Carolina CeladesCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Meghali GoswamiCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Hana BagheriCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Kathleen M SmithSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Ashley J RaineySurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Lindsay R FriedmanSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Carolina LarrainSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Tracey PuSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Surajit SinhaSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Priyanka P DesaiSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Kirsten RemmerSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Audra A SatterwhiteSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Stacy R JoyceSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Aaron J DinermanSurgery Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Bradford J WoodCenter for Interventional Oncology, Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Michael T KassinCenter for Interventional Oncology, Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Ifechi N UkehCenter for Interventional Oncology, Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Andrew M BlakelySurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Jeremy L DavisSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
David E KleinerLaboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Wiem LassouedCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Sofia R GameiroCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Renee N DonahueCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
James L GulleyCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Jeffrey SchlomCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Jonathan M HernandezSurgical Oncology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.

Funding

Interrogating the molecular underpinnings of metastatic colonizationZIABC011759 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HERNANDEZ, JONATHAN · 2017 to 2025
$18.9M
Intramural NIH HHS ZIA BC011759
6 · The paper itself

Abstract

Purpose: Most patients with metastatic colorectal cancer have microsatellite stable or mismatch repair-proficient tumors, which are resistant to immunotherapy especially in cases of liver metastases. We sought to determine if tumor-targeted interleukin-12 (PDS01ADC) can improve outcomes for patients with colorectal cancer liver metastases managed with hepatic artery infusion pump (HAIP) chemotherapy. Patients and Methods: NCT05286814 is a phase II non-randomized trial evaluating subcutaneous PDS01ADC in combination with HAIP floxuridine and systemic chemotherapy (FOLFOX or FOLFIRI) in patients with unresectable microsatellite stable or mismatch repair-proficient colorectal liver metastases previously treated with at least one line of systemic chemotherapy. Primary endpoints for the planned interim analysis were overall response rate and safety. Results: Nine patients were included in this planned interim analysis. 78% (7/9) of patients receiving PDS01ADC with HAIP therapy had partial or complete responses at 6 months. Median hepatic progression-free survival for patients receiving PDS01ADC + HAIP therapy was 12.7 months with minimum follow-up of 13.1 months. Grade ≥3 toxicities occurred in 78% but were manageable and did not limit HAIP therapy. No patients developed a biliary stricture within 6 months of initiating treatment. Clinical responders to PDS01ADC demonstrated enhanced peripheral immune activation, including elevated levels of circulating T cell subsets with stem-like features, and increased CD8+ T cell:T regulatory cell ratio in tissue biopsies. Conclusion: Addition of PDS01ADC is not detrimental to HAIP therapy and is associated with both systemic and intratumoral immune modulation. Initial results warrant continuation to full enrollment for further evaluation of clinical and scientific endpoints.

Identifiers

PMID41937811
PMCPMC13047916

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