Evidence map›Paper›PMID 31218770›Full record

Trial reportCancer science2019

Randomized phase II trial of survivin 2B peptide vaccination for patients with HLA-A24-positive pancreatic adenocarcinoma.

Hiroaki Shima, Giichiro Tsurita, Satoshi Wada, Yoshihiko Hirohashi, Hiroshi Yasui, Hiroshi Hayashi, Takashi Miyakoshi, Kazue Watanabe, Aiko Murai, Hiroko Asanuma and 17 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
–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

45 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Targeting Survivin: Now I Become Death, the Destroyer of Cells.International journal of molecular sciences · 2025
    Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Clinical immunotherapy in pancreatic cancer.Cancer immunology, immunotherapy : CII · 2024
    Review
  16. Article
  17. Review
  18. Tumor vaccines: Toward multidimensional anti-tumor therapies.Human vaccines & immunotherapeutics · 2023
    Review
  19. Article
  20. 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

27 authors.

Hiroaki ShimaDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan.
Giichiro TsuritaDepartment of Surgery, Research Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
Satoshi WadaDepartment of Clinical Diagnostic Oncology, Showa University, Tokyo, Japan.
Yoshihiko HirohashiDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.ORCID https://orcid.org/0000-0002-0608-3914
Hiroshi YasuiThe Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
Hiroshi HayashiHokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan.
Takashi MiyakoshiHokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan.
Kazue WatanabeDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Aiko MuraiDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Hiroko AsanumaDepartment of Surgical Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Serina TokitaDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Terufumi KuboDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Munehide NakatsugawaDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Takayuki KanasekiDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Tomohide TsukaharaDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.ORCID https://orcid.org/0000-0002-3678-4359
Yutaka NakaeCollaboration Center for Community and Industry, Sapporo Medical University School of Medicine, Sapporo, Japan.
Osamu SugitaHokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan.
Yoichi M ItoDepartment of Biostatistics, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Yasunori OtaDepartment of Pathology, Research Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
Yasutoshi KimuraDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan.
Goro KutomiDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan.
Koichi HirataDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan.
Toru MizuguchiDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan.
Kohzoh ImaiThe Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
Ichiro TakemasaDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan.
Noriyuki SatoDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Toshihiko TorigoeDepartment of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.

Funding

Japan Agency for Medical Research and Development 16cm0106309h0001Japan Society for the Promotion of Science 15H04722Japan Society for the Promotion of Science 17H01540
6 · The paper itself

Abstract

The prognosis of advanced pancreatic adenocarcinoma is still extremely poor. This study sought to determine the efficacy of, and immunological response to, peptide vaccination therapy in patients with this disease. In this multicenter randomized phase II study, patients with advanced pancreatic adenocarcinoma after gemcitabine and/or tegafur/gimeracil/oteracil were randomly assigned to 3 groups that each received a 2-step treatment course. In Step 1, the groups received treatments of: (i) survivin 2B peptide (SVN-2B) plus interferon-β (IFNβ); (ii) SVN-2B only; or (iii) placebo until the patients show progression. In Step 2, all patients who consented to participate received 4 treatments with SVN-2B plus IFNβ. The primary endpoint was progression-free survival (PFS) after initiation of Step 1 treatment. Secondary endpoints included immunological effects assessed by analysis of PBMCs after Step 1. Eighty-three patients were randomly assigned to receive SVN-2B plus IFNβ (n = 30), SVN-2B (n = 34), or placebo (n = 19). No significant improvement in PFS was observed. Survivin 2B-specific CTLs were found to be increased in the SVN-2B plus IFNβ group by tetramer assay. Among patients who participated in Step 2, those who had received SVN-2B plus IFNβ in Step 1 showed better overall survival compared with those who had received placebo in Step 1. Patients vaccinated with SVN-2B plus IFNβ did not have improved PFS, but showed significant immunological reaction after vaccination. Subgroup analysis suggested that a longer SVN-2B plus IFNβ vaccination protocol might confer survival benefit. (Clinical trial registration number: UMIN 000012146).

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overCancer VaccinesDeoxycytidineDouble-Blind MethodFemaleGemcitabineHumansInterferon-betaMaleMiddle AgedPancreatic NeoplasmsPeptidesPrognosisCancer VaccinesDeoxycytidineGemcitabineInterferon-betaPeptidesSurvivinVaccines, Subunitimmunotherapyinterferon betapancreatic cancerpeptide vaccinationsurvivin

Identifiers

PMID31218770
PMCPMC6676125

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.