Evidence map›Paper›PMID 42604879›Full record

Trial reportCancer chemotherapy and pharmacology2026

Pharmacokinetic and pharmacodynamic sub-study of trans-arterial vs. intravenous gemcitabine in the TIGeR-PaC phase 3 clinical trial.

Paula M Novelli, Emmanuel E Zervos, Amer H Zureikat, Michael J Pishvaian, Kenneth Meredith, Hassan Hatoum, Reza Nazemzadeh, Sandeep Laroia, Pashtoon Kasi, Justus Bingham and 1 more

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

Trial report in Cancer chemotherapy and pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03257033 (Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer), which is not on this map. Not yet cited in PubMed.

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

NCT03257033 phase3recruitingnot on this map

Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer

TypeinterventionalSponsorRenovoRxRan2018 to 2027Enrolled190ConditionsLocally Advanced Pancreatic CancerArmsGemcitabine, nab-paclitaxel, RenovoCath
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Paula M Novelli *University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Emmanuel E Zervos *Brody School of Medicine at East Carolina University, Greenville, NC, USA. zervose@ecu.edu.
Amer H ZureikatUniversity of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Michael J PishvaianJohns Hopkins University School of Medicine, Washington, DC, USA.
Kenneth MeredithSarasota Memorial Health Care System, Sarasota, FL, USA.
Hassan HatoumUniversity of Oklahoma College of Medicine, Oklahoma City, OK, USA.
Reza NazemzadehLevine Cancer Institute, Charlotte, NC, USA.
Sandeep LaroiaUniversity of Iowa Carver College of Medicine, Iowa City, IA, USA.
Pashtoon KasiCity of Hope, Irvine, CA, USA.
Justus BinghamRenovoRx, Mountain View, CA, USA.
Ramtin AgahRenovoRx, Mountain View, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeLocalized intra-arterial delivery of gemcitabine (IAG) may provide advantages in terms of increased tissue concentration and decreased systemic dosing. We hypothesized IAG may result in decreased systemic gemcitabine concentration and associated side effects due to intracellular delivery prior to conversion to gemcitabine's inactive metabolite, difluorodeoxyuridine (dFdU). Here we report the results of a pharmacokinetics and pharmacodynamics sub-study within the TIGeR-PaC phase 3 clinical trial (NCT03257033).

methodsAnalyses were performed for 16 participants across 6 TIGeR-PaC study sites; 11 participants received localized IAG and 5 participants received systemic intravenous gemcitabine (IVG). Gemcitabine and dFdU assays were performed on blood samples collected immediately before, during, and after infusion. CA 19 - 9 levels were measured prior to and 2 weeks after IAG treatment. Maximum plasma drug concentration (C

resultsIAG resulted in lower gemcitabine C

conclusionIn addition to providing increased local potency, localized IAG, in which gemcitabine is rapidly converted to its inactive metabolite dFdU, may also be beneficial in decreasing gemcitabine-related systemic side effects.

Indexed as

Antimetabolites, AntineoplasticFloxuridineGemcitabinePancreatic NeoplasmsAgedArea Under CurveCA-19-9 AntigenDeoxycytidineFemaleHumansInfusions, Intra-ArterialInfusions, IntravenousMaleMiddle Aged2',2'-difluoro-2'-deoxyuridineAntimetabolites, AntineoplasticCA-19-9 AntigenDeoxycytidineFloxuridineGemcitabineGemcitabineIntra-arterial chemotherapyLocally advanced pancreatic cancer (LAPC)Trans-arterial micro perfusion (TAMP)

Identifiers

PMID42604879
PMCPMC13478025

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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.