Evidence map›Paper›PMID 32219501›Full record

ArticleCancer immunology, immunotherapy : CII2020

A phase I study of multi-HLA-binding peptides derived from heat shock protein 70/glypican-3 and a novel combination adjuvant of hLAG-3Ig and Poly-ICLC for patients with metastatic gastrointestinal cancers: YNP01 trial.

Masao Nakajima, Shoichi Hazama, Koji Tamada, Keiko Udaka, Yasunobu Kouki, Toshinari Uematsu, Hideki Arima, Akira Saito, Shun Doi, Hiroto Matsui and 14 more

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
0.8field-weighted citation impact, top 29% 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.

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

15 citing papers in PubMed, 23 citations in OpenAlex.

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  5. Targeted apoptotic immune modulator for the treatment of metastatic EGFR-positive solid tumors.Proceedings of the National Academy of Sciences of the United States of America · 2025
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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

24 authors at 5 institutions in 1 country.

Masao NakajimaDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Shoichi HazamaDepartment of Translational Research and Developmental Therapeutics Against Cancer, Yamaguchi University School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Koji TamadaDepartment of Immunology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Keiko UdakaDepartment of Immunology, Kochi Medical School, Nankoku, Kochi, 783-8505, Japan.
Yasunobu KoukiDepartment of Pharmacy, Yamaguchi University Hospital, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Toshinari UematsuDepartment of Pharmacy, Yamaguchi University Hospital, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Hideki ArimaDepartment of Pharmacy, Yamaguchi University Hospital, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Akira SaitoDepartment of AI Applied Quantitative Clinical Science, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku, Tokyo, 160-8402, Japan.
Shun DoiCYTLIMIC Inc, Shinagawa, Tokyo, 141-0021, Japan.
Hiroto MatsuiDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Yoshitaro ShindoDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Satoshi MatsukumaDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Shinsuke KanekiyoDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Yukio TokumitsuDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Shinobu TomochikaDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Michihisa IidaDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Shin YoshidaDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Yuki NakagamiDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Nobuaki SuzukiDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Shigeru TakedaDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Shigeru YamamotoDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Shigefumi YoshinoOncology Center, Yamaguchi University Hospital, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Tomio UenoDepartment of Digestive Surgery, Kawasaki University School of Medicine, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.
Hiroaki NaganoDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan. hnagano@yamaguchi-u.ac.jp.
Yamaguchi University · JPYamaguchi University Hospital · JPKawasaki Medical School · JPKōchi University · JPTokyo Medical University · JP

Funding

NEC Corporation noen
6 · The paper itself

Abstract

backgroundThis phase I study aimed to evaluate the safety, peptide-specific immune responses, and anti-tumor effects of a novel vaccination therapy comprising multi-HLA-binding heat shock protein (HSP) 70/glypican-3 (GPC3) peptides and a novel adjuvant combination of hLAG-3Ig and Poly-ICLC against metastatic gastrointestinal cancers.

methodsHSP70/GPC3 peptides with high binding affinities for three HLA types (A*24:02, A*02:01, and A*02:06) were identified with our peptide prediction system. The peptides were intradermally administered with combined adjuvants on a weekly basis. This study was a phase I dose escalation clinical trial, which was carried out in a three patients' cohort; in total, 11 patients were enrolled for the recommended dose.

resultsSeventeen patients received this vaccination therapy without dose-limiting toxicity. All treatment-related adverse events were of grades 1 to 2. Peptide-specific CTL induction by HSP70 and GPC3 proteins was observed in 11 (64.7%) and 13 (76.5%) cases, respectively, regardless of the HLA type. Serum tumor marker levels were decreased in 10 cases (58.8%). Immunological analysis using PBMCs indicated that patients receiving dose level 3 presented with significantly reduced T cell immunoglobulin and mucin-domain containing-3 (TIM3)-expressing CD4 + T cells after one course of treatment. PD-1 or TIM3-expressing CD4 + T cells and T cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT)-expressing CD8 + T cells in PBMCs before vaccination were negative predictive factors for survival.

conclusionsThis novel peptide vaccination therapy was safe for patients with metastatic gastrointestinal cancers.

Indexed as

Adjuvants, ImmunologicAdultAgedAged, 80 and overCarboxymethylcellulose SodiumCohort StudiesFemaleFollow-Up StudiesGastrointestinal NeoplasmsGlypicansHLA-A AntigensHLA-G AntigensHSP70 Heat-Shock ProteinsHumansMaleMiddle AgedAdjuvants, ImmunologicCarboxymethylcellulose SodiumGlypicansGPC3 protein, humanHLA-A AntigensHLA-G AntigensHSP70 Heat-Shock ProteinsPeptide FragmentsPoly I-Cpoly ICLCPolylysineGastrointestinal cancersHLAG-3Ig plus Poly-ICLCMulti-HLA bindingPeptide vaccination therapy

Identifiers

PMID32219501
PMCPMC7347520
OpenAlexW3013632761

What OpenQuestion holds

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Registered trials

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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.