Evidence map›Paper›PMID 28188670›Full record

Trial reportCancer science2017

A randomized phase II trial of personalized peptide vaccine with low dose cyclophosphamide in biliary tract cancer.

Takahisa Shirahama, Daisuke Muroya, Satoko Matsueda, Akira Yamada, Shigeki Shichijo, Masayasu Naito, Takuto Yamashita, Shinjiro Sakamoto, Koji Okuda, Kyogo Itoh and 2 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
4.0field-weighted citation impact, top 6% 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

26 citing papers in PubMed, 43 citations in OpenAlex.

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  9. Immunology and immunotherapy of cholangiocarcinoma.Nature reviews. Gastroenterology & hepatology · 2023
    Review
  10. Combination Therapies for Advanced Biliary Tract Cancer.Journal of clinical and translational hepatology · 2023
    Review
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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

12 authors at 1 institution in 1 country.

Takahisa ShirahamaDepartment of Surgery, Kurume University School of Medicine, Kurume, Japan.
Daisuke MuroyaDepartment of Surgery, Kurume University School of Medicine, Kurume, Japan.
Satoko MatsuedaCancer Vaccine Center, Kurume University, Kurume, Japan.
Akira YamadaResearch Center for Innovative Cancer Therapy, Kurume University, Kurume, Japan.
Shigeki ShichijoCancer Vaccine Center, Kurume University, Kurume, Japan.
Masayasu NaitoCancer Vaccine Center, Kurume University, Kurume, Japan.
Takuto YamashitaDepartment of Biostatistics Center, Kurume University School of Medicine, Kurume, Japan.
Shinjiro SakamotoResearch Center for Innovative Cancer Therapy, Kurume University, Kurume, Japan.ORCID http://orcid.org/0000-0002-2805-900X
Koji OkudaDepartment of Surgery, Kurume University School of Medicine, Kurume, Japan.
Kyogo ItohCancer Vaccine Center, Kurume University, Kurume, Japan.
Tetsuro SasadaCancer Vaccine Center, Kurume University, Kurume, Japan.ORCID http://orcid.org/0000-0002-2313-8833
Shigeru YutaniCancer Vaccine Center, Kurume University, Kurume, Japan.ORCID http://orcid.org/0000-0001-6306-4130
Kurume University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Since the prognosis of advanced biliary tract cancer (aBTC) still remains very poor, new therapeutic approaches, including immunotherapies, need to be developed. In the current study, we conducted an open-label randomized phase II study to test whether low dose cyclophosphamide (CPA) could improve antigen-specific immune responses and clinical efficacy of personalized peptide vaccination (PPV) in 49 previously treated aBTC patients. Patients with aBTC refractory to at least one regimen of chemotherapies were randomly assigned to receive PPV with low dose CPA (100 mg/day for 7 days before vaccination) (PPV/CPA, n = 24) or PPV alone (n = 25). A maximum of four HLA-matched peptides were selected based on the pre-existing peptide-specific IgG responses, followed by subcutaneous administration. T cell responses to the vaccinated peptides in the PPV/CPA arm tended to be greater than those in the PPV alone arm. The PPV/CPA arm showed significantly better progression-free survival (median time: 6.1 vs 2.9 months; hazard ratio (HR): 0.427; P = 0.008) and overall survival (median time: 12.1 vs 5.9 months; HR: 0.376; P = 0.004), compared to the PPV alone arm. The PPV alone arm, but not the PPV/CPA arm, showed significant increase in plasma IL-6 after vaccinations, which might be associated with inhibition of antigen-specific T cell responses. These results suggested that combined treatment with low dose CPA could provide clinical benefits in aBTC patients under PPV, possibly through prevention of IL-6-mediated immune suppression. Further clinical studies would be recommended to clarify the clinical efficacy of PPV/CPA in aBTC patients.

Indexed as

AgedBiliary Tract NeoplasmsCancer VaccinesCyclophosphamideDisease-Free SurvivalFemaleHumansImmunotherapyInterleukin-6MaleMiddle AgedPeptidesPrecision MedicineVaccinationCancer VaccinesCyclophosphamideInterleukin-6PeptidesBiliary tract cancercyclophosphamideIL-6peptide vaccinerandomized phase II clinical trial

Identifiers

PMID28188670
PMCPMC5448649
OpenAlexW2586374151

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.