Evidence map›Paper›PMID 29587677›Full record

ArticleBMC cancer2018

A phase I/Ib study of OTSGC-A24 combined peptide vaccine in advanced gastric cancer.

Raghav Sundar, Sun Young Rha, Hiroki Yamaue, Masahiro Katsuda, Koji Kono, Hyo Song Kim, Chan Kim, Kousaku Mimura, Ley-Fang Kua, Wei Peng Yong

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01227772 (A Phase I/IIa Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% 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.

NCT01227772 phase1 / phase2unknown statusnot on this map

A Phase I/IIa Study of OTSGC-A24 Vaccine in Advanced Gastric Cancer

TypeinterventionalSponsorNational University Hospital, SingaporeRan2010 to 2017Enrolled23ConditionsGastric CancerArmsOTSGC-A24
3 · Its place in the literature

Who cites it

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

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  18. Combined inhibition of PD-1/PD-L1, Lag-3, and Tim-3 axes augments antitumor immunity in gastric cancer-T cell coculture models.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2021
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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

10 authors at 6 institutions in 3 countries.

Raghav SundarDepartment of Haematology-Oncology, National University Health System, 5 Lower Kent Ridge Road, Main Building Level 2, Singapore, S119074, Singapore.
Sun Young RhaYonsei Cancer Center, Seoul, South Korea.
Hiroki YamaueWakayama Medical University Hospital, Wakayama, Japan.
Masahiro KatsudaWakayama Medical University Hospital, Wakayama, Japan.
Koji KonoCancer Science Institute, National University of Singapore, Singapore, Singapore.
Hyo Song KimYonsei Cancer Center, Seoul, South Korea.
Chan KimYonsei Cancer Center, Seoul, South Korea.
Kousaku MimuraDepartment of Gastrointestinal Tract Surgery, Fukushima Medical University, Fukushima, Japan.
Ley-Fang KuaCancer Science Institute, National University of Singapore, Singapore, Singapore.
Wei Peng YongDepartment of Haematology-Oncology, National University Health System, 5 Lower Kent Ridge Road, Main Building Level 2, Singapore, S119074, Singapore. wei_peng_yong@nuhs.edu.sg.
Yonsei University · KRFukushima Medical University · JPWakayama Medical University · JPNational University Cancer Institute, Singapore · SGNational University Health System · SGNational University of Singapore · SG

Funding

National Medical Research Council TCR Flagship and Centre Grant NMRC/TCR/009-NUHS/2013
6 · The paper itself

Abstract

backgroundWe conducted a phase I/Ib, open-label, single-arm trial to assess the safety, tolerability and optimal scheduling regimen of OTSGC-A24 cancer vaccine in patients with advanced gastric cancer.

methodsPatients with advanced gastric cancer with HLA-A*24:02 haplotype were included in this study. OTSGC-A24 was administered at 1 mg in 3-weekly (3w), 2-weekly (2w), and weekly (1w) cohorts to evaluate the safety, immunological response and schedule. Based on the highest specific cytotoxic T lymphocyte (CTL) induction rate at 4 weeks, using the ELISPOT test, cohorts were expanded to define the optimal dosing schedule for OTSGC-A24.

resultsIn this study, 24 advanced gastric cancer patients with HLA-A*24:02 haplotype were enrolled and treated in 3 cohorts (3w cohort: 3; 2w cohort: 11 and 1w cohort: 10 patients). The most common adverse events were decreased appetite (29%), diarrhea (21%), myalgia (25%). The most common treatment-related adverse event was injection site erythema (25%). No dose-limiting toxicities were observed in any cohort and OTSGC-A24 was well tolerated. Positive CTL responses after vaccination were observed in 15 patients (75%) at 4 weeks: 3w cohort (33%), 2w cohort (88%), 1w cohort (78%). At 12 weeks, 18 patients had responded (90%); 3w cohort (100%), 2w cohort (100%), 1w cohort (78%). The best radiological was stable disease (40%). Median progression free survival was 1.7 months (95% CI: 1.4 to 3.5) and median overall survival was 5.7 months (95% CI 3.8 to 8.6).

conclusionsOTSGC-A24 combined peptide cancer vaccine was well tolerated. Significant responses in CTL were observed and the recommended phase 2 dose is 1 mg OTSGC-A24 sub-cutaneous, every 2 weeks. Although no radiological response was observed, a respectable overall survival was achieved, consistent with other immunotherapy agents being investigated in gastric cancer.

trial registrationClinicalTrials.gov Identifier: NCT01227772 , Date registered: 21 Oct 2010.

Indexed as

AdultAgedBiomarkersCancer VaccinesCombined Modality TherapyCytotoxicity, ImmunologicFemaleHaplotypesHLA-A24 AntigenHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingStomach NeoplasmsT-Lymphocytes, CytotoxicBiomarkersCancer VaccinesHLA-A24 AntigenVaccines, SubunitCancer vaccineGastric cancerOTSGC-A24Phase I

Identifiers

PMID29587677
PMCPMC5870101
OpenAlexW2228486038

What OpenQuestion holds

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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.