Evidence map›Paper›PMID 40468090›Full record

ArticleInvestigational new drugs2025

A phase I study of liposomal Irinotecan (ONIVYDE®) in combination with TAS-102 (LONSURF®) in refractory solid tumors.

Nai-Jung Chiang, Li-Yuan Bai, I-Wei Ho, Chih-Hung Hsu, Yi-Hsin Liang, Chang-Fang Chiu, Ching-Chan Lin, Kwang-Yu Chang, Shang-Hung Chen, Hui-Jen Tsai and 3 more

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Investigational new drugs, 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. Review
  2. Review
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

13 authors.

Nai-Jung ChiangDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Li-Yuan Bai *Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital and China Medical University, Taichung, Taiwan.
I-Wei HoDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Chih-Hung HsuDepartments of Oncology, College of Medicine, National Taiwan University Hospital and Graduate Institute of Oncology, National Taiwan University, Zhongshan S. Rd, Taipei, 10002, Taiwan.
Yi-Hsin LiangDepartments of Oncology, College of Medicine, National Taiwan University Hospital and Graduate Institute of Oncology, National Taiwan University, Zhongshan S. Rd, Taipei, 10002, Taiwan.
Chang-Fang ChiuDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital and China Medical University, Taichung, Taiwan.
Ching-Chan LinDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital and China Medical University, Taichung, Taiwan.
Kwang-Yu ChangNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Shang-Hung ChenNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Hui-Jen TsaiNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Yu-Ping LinPharmaEngine, Inc., Taipei, Taiwan.
Li-Tzong Chen *National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Chia-Chi Lin *Departments of Oncology, College of Medicine, National Taiwan University Hospital and Graduate Institute of Oncology, National Taiwan University, Zhongshan S. Rd, Taipei, 10002, Taiwan. cclin1@ntu.edu.tw.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Onivyde, a liposome-encapsulated irinotecan, is used for advanced pancreatic, while TAS-102 (trifluridine/tipiracil) is indicated for metastatic colorectal and gastric cancers. This study aims to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), and safety profiles of liposomal irinotecan combined with TAS-102. This multicenter, phase I study utilized a 3 + 3 dose-escalation design. Patients with treatment-refractory solid malignancies received free base liposomal irinotecan at 50-70 mg/m

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsIrinotecanNeoplasmsTrifluridineUracilAdultAgedDrug CombinationsFemaleHumansLiposomesMaleMaximum Tolerated DoseMiddle AgedPyrrolidinesThymineDrug CombinationsIrinotecanLiposomesPyrrolidinesThymineTrifluridinetrifluridine tipiracil drug combinationUracilEfficacyLiposomal irinotecanPharmacokineticsPhase 1 clinical trialSolid tumorsTAS-102

Identifiers

PMID40468090
PMCPMC12310894

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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.