Evidence map›Paper›PMID 41117518›Full record

Trial reportCancer medicine2025

Nanoliposomal Irinotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Head and Neck and Esophageal Squamous Cell Carcinoma After Prior Platinum-Based Chemotherapy or Chemoradiotherapy: A Multicenter Phase II Trial.

Muh-Hwa Yang, Shang-Yin Wu, I-Wei Ho, Nai-Jung Chiang, Chin-Fu Hsaio, Chen-Yuan Lin, Ming-Yu Lien, Peter Mu-Hsin Chang, Jia-Hong Chen, Ching-Yun Hsieh and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03712397 (Phase 2 Study of Nanoliposomal Irinotecan), which is not on this 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.

NCT03712397 phase2completednot on this map

Phase 2 Study of Nanoliposomal Irinotecan (Nal-IRI, PEP02, MM-398, Onivyde®) With 5-FU and Leucovorin in Squamous Cell Carcinoma (SCC) of Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy

TypeinterventionalSponsorNational Health Research Institutes, TaiwanRan2018 to 2022Enrolled59ConditionsHead & Neck CancerArmsnanoliposomal irinotecan
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  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

16 authors.

Muh-Hwa YangDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.ORCID https://orcid.org/0000-0001-7722-9506
Shang-Yin WuDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
I-Wei HoDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Nai-Jung ChiangDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Chin-Fu HsaioInstitute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.
Chen-Yuan LinDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Ming-Yu LienDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Peter Mu-Hsin ChangDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Jia-Hong ChenDivision of Hematology and Oncology, Department of Internal Medicine, Tri-Service General Hospital, Taipei, Taiwan.
Ching-Yun HsiehDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Ruey-Long HongDepartment of Oncology, National Taiwan University, Taipei, Taiwan.
Chao-Tung LeeNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Li-Tzong ChenDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.ORCID https://orcid.org/0000-0003-3250-7167
Tsang-Wu LiuNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
Chang-Fang ChiuDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Li-Yuan BaiDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.ORCID https://orcid.org/0000-0001-7739-4077

Funding

National Health Research Institutes NHRI-114A1-CACO-13252502Taiwan Minstry of Science and Technology MOST 114-2314-B-039-076
6 · The paper itself

Abstract

purposeTo evaluate the efficacy and safety of nanoliposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU) and leucovorin (LV) in patients with platinum-refractory or intolerant head and neck squamous cell carcinoma (HNSCC) and esophageal squamous cell carcinoma (ESCC).

methodsIn this multicenter, phase 2 study (NCT03712397), patients with advanced HNSCC (n = 43) or ESCC (n = 16) who had failed or were intolerant to platinum-based chemotherapy received biweekly nal-IRI 80 mg/m

resultsIn the intent-to-treat analysis, the ORR and disease control rate were 8.5% and 59.3% for the entire group. In the HNSCC subgroup, ORR and disease control rate were 11.6% and 65.1%, with a median progression-free survival (PFS) of 2.7 months and an overall survival (OS) of 8.1 months. By contrast, no objective responses were observed in ESCC (ORR 0%, disease control rate 43.8%, median OS 4.2 months). The most common grade 3/4 toxicities were lymphopenia (50.8%), neutropenia (42.4%), leukopenia (33.9%), anemia (28.8%), and anorexia (8.5%).

conclusionsNal-IRI/5-FU/LV demonstrates modest activity with acceptable safety profiles in patients with platinum-refractory or intolerable advanced HNSCC. The exploratory findings warrant confirmation in larger, randomized studies.

trial registrationClinicalTrials.gov: NCT03712397.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaHead and Neck NeoplasmsIrinotecanSquamous Cell Carcinoma of Head and NeckAdultAgedChemoradiotherapyFemaleFluorouracilHumansLeucovorinLiposomesMaleMiddle AgedFluorouracilIrinotecanLeucovorinLiposomesesophageal cancerhead and neck cancernanoliposomal irinotecanplatinumsquamous cell carcinoma

Identifiers

PMID41117518
PMCPMC12538807

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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.