Evidence map›Paper›PMID 40696453›Full record

Trial reportMolecular cancer2025

An immune responsive tumor microenvironment imprints into PBMCs and predicts outcome in advanced pancreatic cancer: lessons from the PREDICT trial.

Anton Lahusen, Manfred P Lutz, Rui Fang, Martina Kirchner, Sarah Albus, Klaus Kluck, Meinolf Karthaus, Andreas Schwarzer, Gabriele Siegler, Alexander Kleger and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Molecular cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03468335 (Second-line Therapy With Nal-IRI After Failure Gemcitabine/Nab-paclitaxel in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy), 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.

NCT03468335 phase3completednot on this map

Second-line Therapy With Nal-IRI After Failure Gemcitabine/Nab-paclitaxel in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy

TypeinterventionalSponsorAIO-Studien-gGmbHRan2018 to 2022Enrolled151ConditionsLocally Advanced Pancreatic Cancer, Metastatic Pancreatic CancerArmsIrinotecan Liposomal Injection [Onivyde]
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
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  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

20 authors.

Anton LahusenDepartment of Internal Medicine I, Ulm University Hospital, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Manfred P LutzDepartment of Gastroenterology, Caritas Klinikum Saarbrücken St. Theresia, Saarbrücken, Germany.
Rui FangBridge Institute of Experimental Tumor Therapy (BIT), West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Martina KirchnerInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Sarah AlbusInstitute of Pathology, Ruhr University Bochum, Bochum, Germany.
Klaus KluckInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Meinolf KarthausDepartment of Hematology, Oncology, and Palliative Care, München Klinik Harlaching and Neuperlach, München, Germany.
Andreas SchwarzerOnkopraxis Probstheida, Leipzig, Germany.
Gabriele SieglerHämatologie/Onkologie, Klinikum Nürnberg Nord/Paracelsus Medizinische Privatuniversität, Nürnberg, Germany.
Alexander KlegerInstitute for Molecular Oncology and Stem Cell Biology, Ulm University Hospital, Ulm, Germany.
Thomas J EttrichDepartment of Internal Medicine I, Ulm University Hospital, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Alexander BecherDepartment of Internal Medicine I, Ulm University Hospital, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Sabine HöflingCROLLL GmbH, Nürnberg, Germany.
Jens T SivekeBridge Institute of Experimental Tumor Therapy (BIT), West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Jan BudcziesInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Andrea TannapfelInstitute of Pathology, Ruhr University Bochum, Bochum, Germany.
Albrecht StenzingerInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Phyllis Fung-Yi CheungBridge Institute of Experimental Tumor Therapy (BIT), West German Cancer Center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Tim Eiseler *Department of Internal Medicine I, Ulm University Hospital, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Thomas Seufferlein *Department of Internal Medicine I, Ulm University Hospital, Albert-Einstein-Allee 23, 89081, Ulm, Germany. thomas.seufferlein@uniklinik-ulm.de.

Funding

Servier Deutschland GmbH PREDICT
6 · The paper itself

Abstract

backgroundPrognosis in advanced pancreatic ductal adenocarcinoma (aPDAC) is particularly poor, only few patients benefit from treatment, and there are few biomarkers. The PREDICT trial examined whether first-line time-to-treatment failure (TTF1) predicts second-line treatment failure (TTF2) in aPDAC patients but found no association. We hypothesized that the tumor immune microenvironment (TiME) could correlate with the outcome in this trial and assessed whether tissue features were reflected in peripheral blood.

methodsPREDICT patients received 5-FU/LV plus nanoliposomal irinotecan as second-line treatment. We stratified patients by shortest vs. longest TTF2 and analyzed 20 treatment-naïve tumor tissues samples via transcriptomics and immunohistochemistry. Peripheral blood mononuclear cells (PBMCs) from 82 patients collected prior to second-line therapy underwent flow cytometry and gene expression profiling. A machine learning pipeline integrated PBMC and clinical data to predict second-line outcome including external validation in 30 patients.

resultsLong-TTF2 tumors exhibited an immune-active ("hot") TiME with cytotoxic CXCR3

conclusionsAn immune-active, treatment-naïve TiME predicts a better second-line outcome, and these characteristics imprinted into PBMCs obtained after one line of chemotherapy. We here first describe a minimally invasive, PBMC-based predictor of second-line outcome as a powerful prognostic tool for triaging patients.

trial registrationClinicalTrials.gov NCT03468335 (registered March 15, 2018).

Indexed as

Carcinoma, Pancreatic DuctalLeukocytes, MononuclearPancreatic NeoplasmsTumor MicroenvironmentAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorFemaleGene Expression ProfilingHumansMaleMiddle AgedPrognosisTreatment OutcomeBiomarkers, TumorAdvanced pancreatic ductal adenocarcinomaImmunophenotypingLiquid biomarkersMachine learningPeripheral blood mononuclear cellsSecond-line chemotherapyTumor immune microenvironment

Identifiers

PMID40696453
PMCPMC12281745

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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.