Evidence map›Paper›PMID 39987459›Full record

ArticleFuture oncology (London, England)2025

NALIRIFOX in Japanese treatment-naïve patients with metastatic pancreatic adenocarcinoma: an open-label, phase II trial design.

Masafumi Ikeda, Takuji Okusaka, Makoto Ueno, Masato Ozaka, Sohei Satoi, Donia Skanji, L Martín-Fernández, Nadia Amellal, Junji Furuse

Abstract readClinical Trial Protocol
In one paragraph

Article in Future oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

9 authors.

Masafumi IkedaNational Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-4050-2086
Takuji OkusakaNational Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0003-1729-807X
Makoto UenoKanagawa Cancer Center, Yokohama, Japan.ORCID 0000-0003-4480-0029
Masato OzakaCancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0002-5666-1970
Sohei SatoiKansai Medical University, Osaka, Japan.ORCID 0000-0001-6527-5409
Donia SkanjiInstitut de Recherches Internationales Servier, Gif sur Yvette, France.ORCID 0009-0009-0218-9584
L Martín-FernándezInstitut de Recherches Internationales Servier, Gif sur Yvette, France.ORCID 0000-0003-4731-7753
Nadia AmellalInstitut de Recherches Internationales Servier, Gif sur Yvette, France.ORCID 0000-0002-6171-6729
Junji FuruseKanagawa Cancer Center, Yokohama, Japan.ORCID 0000-0003-0663-6117

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This is a single arm, open label trial to assess the safety and efficacy of NALIRIFOX in Japanese participants who have not previously received therapy for metastatic adenocarcinoma of the pancreas. Forty-one participants will receive the treatment NALIRIFOX (liposomal irinotecan, 5-fluorouracil, levoleucovorin and oxaliplatin) until progression or unacceptable toxicity. Anti-tumor activity will be evaluated in terms of objective response rate according to RECIST v1.1 by independent central review. Safety will be carefully monitored, with a dedicated Safety Monitoring Committee reviewing the data from the initial six participants to safeguard the well-being of all individuals involved in the study. Other evaluations will include pharmacokinetics and the relationship between mutations in the UGT1A1 genes and safety. This study aims to show that the results of the NAPOLI 3 study in the global population can be reproduced in the Japanese population.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsPancreatic NeoplasmsAdultAgedClinical Trials, Phase II as TopicEast Asian PeopleFemaleFluorouracilGlucuronosyltransferaseHumansIrinotecanJapanLeucovorinMaleMiddle AgedFluorouracilGlucuronosyltransferaseIrinotecanLeucovorinOrganoplatinum CompoundsOxaliplatinAsianbridging studygemcitabine/nabpaclitaxelJapaneseliposomal irinotecanmetastatic pancreatic cancerNALIRIFOXNAPOLI 3

Identifiers

PMID39987459
PMCPMC11938982

What OpenQuestion holds

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Registered trials

None linked

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.