Evidence map›Paper›PMID 37708904›Full record

Trial reportLancet (London, England)2023

NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial.

Zev A Wainberg, Davide Melisi, Teresa Macarulla, Roberto Pazo Cid, Sreenivasa R Chandana, Christelle De La Fouchardière, Andrew Dean, Igor Kiss, Woo Jin Lee, Thorsten O Goetze and 9 more

5 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 319 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
319citing papers in PubMed, 9 pooled it
91.6field-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.

NCT04106856 phase1completednot on this map

SHAPER: A Phase 1 Study of Losartan and Hypofractionated Radiation Therapy After Induction Chemotherapy for Borderline Resectable or Locally Advanced Pancreatic Cancer

TypeinterventionalSponsorUniversity of UtahRan2019 to 2026Enrolled22ConditionsBorderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma, Locally Advanced Unresectable Pancreatic Adenocarcinoma, Stage II Pancreatic Cancer AJCC v8ArmsHypofractionated Radiation Therapy, Losartan, Losartan Potassium
NCT06538623 phase2completednot on this mapstarted 2024, after this paper: background citation

Single-arm, Open-label Clinical Study of Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-Fluorouracil/Leucovorin (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer After First-line Therapy Failure With AG Regimen

TypeinterventionalSponsorRuijin HospitalRan2024 to 2025Enrolled40ConditionsPancreatic Neoplasms, Neoplasm Metastasis, Hepatic Metastasis of Pancreatic CancerArmsLiposome Irinotecan Injection II combined with Oxaliplatin, Fluorouracil, Leucovorin, Tegodor
NCT06736717 phase1 / phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Phase 1b/2 Trial of Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2025 to 2027Enrolled21ConditionsPancreatic CancerArmsOnvansertib, NALIRIFOX
NCT07173387 phase2active not recruitingnot on this mapstarted 2025, after this paper: background citation

Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer: A Prospective Clinical Trial

TypeinterventionalSponsorShandong Cancer Hospital and InstituteRan2025 to 2028Enrolled42ConditionsPancreatic CancerArmsNALIRIFOX (liposomal irinotecan-based chemotherapy)., Stereotactic Body Radiation Therapy (SBRT).
NCT07595172 phase1 / phase2recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase I/II Clinical Trial of NALIRIFOX Combined With Adebrelimab and PULSAR as First-Line Treatment for Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma

TypeinterventionalSponsorWest China HospitalRan2026 to 2029Enrolled55ConditionsPancreatic Ductal Adenocarcinoma (PDAC), Locally Advanced and Metastatic Pancreatic CancerArmsNALIRIFOX+Adebrelimab, PULSAR
3 · Its place in the literature

Who cites it

319 citing papers in PubMed, 9 syntheses or guidelines pooled it, 396 citations in OpenAlex.

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  16. Impact ofFuture oncology (London, England) · 2026
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259 more citing papers are in PubMed but not listed here.

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

19 authors at 17 institutions in 10 countries.

Zev A WainbergDavid Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA. Electronic address: zwainberg@mednet.ucla.edu.
Davide MelisiUniversità degli studi di Verona and Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
Teresa MacarullaVall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Roberto Pazo CidHospital Universitario Miguel Servet, Zaragoza, Spain.
Sreenivasa R ChandanaCancer and Hematology Centers of Western Michigan, Grand Rapids, MI, USA.
Christelle De La FouchardièreCentre Léon Bérard, Lyon, France.
Andrew DeanSt John of God Subiaco Hospital, Subiaco, WA, Australia.
Igor KissMasaryk Memorial Cancer Institute, Brno, Czech Republic.
Woo Jin LeeNational Cancer Center, Goyang, South Korea.
Thorsten O GoetzeKrankenhaus Nordwest, Frankfurt am Main, Germany.
Eric Van CutsemUniversity Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.
A Scott PaulsonTexas Oncology-Baylor Charles A Sammons Cancer Center, Dallas, TX, USA.
Tanios Bekaii-SaabMayo Clinic, Scottsdale, AZ, USA.
Shubham PantMD Anderson Cancer Center, Houston, TX, USA.
Richard A HubnerThe Christie NHS Foundation Trust, and Division of Cancer Sciences, University of Manchester, Manchester, UK.
Zhimin XiaoIpsen, Cambridge, MA, USA.
Huanyu ChenIpsen, Cambridge, MA, USA.
Fawzi BenzaghouIpsen, Cambridge, MA, USA.
Eileen M O'ReillyMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Ipsen (United States) · USAzienda Ospedaliera Universitaria Integrata Verona · ITCentre Léon Bérard · FRHematology Oncology Consultants · USHospital Universitario Miguel Servet · ESKrankenhaus Nordwest · DEMasaryk Memorial Cancer Institute · CZMayo Clinic in Arizona · USMemorial Sloan Kettering Cancer Center · USNational Cancer Center · KRSt John of God Subiaco Hospital · AUTexas Oncology · USThe Christie NHS Foundation Trust · GBThe University of Texas MD Anderson Cancer Center · USUniversitair Ziekenhuis Leuven · BEUniversity of California, Los Angeles · USVall d'Hebron Institute of Oncology

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Total Neoadjuvant Therapy (TNT) for Borderline Resectable and Locally Advanced Pancreatic AdenocarcinomaP50CA257881 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI Alice Chia- chi Wei · 2022 to 2026
$14.3M
NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA257881
6 · The paper itself

Abstract

backgroundPancreatic ductal adenocarcinoma remains one of the most lethal malignancies, with few treatment options. NAPOLI 3 aimed to compare the efficacy and safety of NALIRIFOX versus nab-paclitaxel and gemcitabine as first-line therapy for metastatic pancreatic ductal adenocarcinoma (mPDAC).

methodsNAPOLI 3 was a randomised, open-label, phase 3 study conducted at 187 community and academic sites in 18 countries worldwide across Europe, North America, South America, Asia, and Australia. Patients with mPDAC and Eastern Cooperative Oncology Group performance status score 0 or 1 were randomly assigned (1:1) to receive NALIRIFOX (liposomal irinotecan 50 mg/m

findingsBetween Feb 19, 2020 and Aug 17, 2021, 770 patients were randomly assigned (NALIRIFOX, 383; nab-paclitaxel-gemcitabine, 387; median follow-up 16·1 months [IQR 13·4-19·1]). Median overall survival was 11·1 months (95% CI 10·0-12·1) with NALIRIFOX versus 9·2 months (8·3-10·6) with nab-paclitaxel-gemcitabine (hazard ratio 0·83; 95% CI 0·70-0·99; p=0·036). Grade 3 or higher treatment-emergent adverse events occurred in 322 (87%) of 370 patients receiving NALIRIFOX and 326 (86%) of 379 patients receiving nab-paclitaxel-gemcitabine; treatment-related deaths occurred in six (2%) patients in the NALIRIFOX group and eight (2%) patients in the nab-paclitaxel-gemcitabine group.

interpretationOur findings support use of the NALIRIFOX regimen as a possible reference regimen for first-line treatment of mPDAC.

fundingIpsen. TRANSLATION: For the plain language summary see Supplementary Materials section.

Indexed as

AdenocarcinomaPancreatic NeoplasmsAlbuminsAntineoplastic Combined Chemotherapy ProtocolsGemcitabineHumansPaclitaxel130-nm albumin-bound paclitaxelAlbuminsGemcitabinePaclitaxel

Identifiers

PMID37708904
PMCPMC11664154
OpenAlexW4386614978

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.