Evidence map›Paper›PMID 41403286›Full record

ArticleFuture oncology (London, England)2025

Feasibility of antibiotic-assisted fecal microbiota transplantation with immunotherapy for esophageal and gastric cancer.

Yuri Yoshinami, Shotaro Yamaguchi, Hirokazu Shoji, Natsuko Okita, Hiroyuki Takamaru, Toshiharu Hirose, Hidekazu Hirano, Atsuo Takashima, Hiroshi Imazeki, Shun Yamamoto and 7 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Future oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

2 citing papers in PubMed.

  1. Review
  2. Review
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

17 authors.

Yuri YoshinamiDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Shotaro YamaguchiDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Hirokazu ShojiDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Natsuko OkitaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Hiroyuki TakamaruEndoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Toshiharu HiroseDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Hidekazu HiranoDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Atsuo TakashimaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Hiroshi ImazekiDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Shun YamamotoDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Shohei KoyamaDepartment of Immuno Genomic Medicine, Research Institute, National Cancer Center, Tokyo, Japan.
Dai IshikawaResearch and Development Division, Metagen Therapeutics Inc., Yamagata, Japan.
Jun TerauchiResearch and Development Division, Metagen Therapeutics Inc., Yamagata, Japan.
Kazuki TanakaResearch and Development Division, Metagen Therapeutics Inc., Yamagata, Japan.
Kana OgawaResearch and Development Division, Metagen Therapeutics Inc., Yamagata, Japan.
Hikaru WatanabeResearch and Development Division, Metagen Therapeutics Inc., Yamagata, Japan.
Ken KatoDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsImmune checkpoint inhibitors (ICIs) have improved outcomes in several malignancies, but survival remains poor for patients with unresectable advanced or recurrent esophageal or gastric cancer. Recent evidence suggests that modulation of the intestinal microbiota may influence the therapeutic response to ICIs. This study aims to evaluate the safety and preliminary efficacy of fecal microbiota transplantation following antibiotic pretreatment (A-FMT) in patients scheduled to receive ICI-containing regimens.

methodsThis phase I - II, single-institution clinical trial enrolls patients with unresectable advanced or recurrent esophageal or gastric cancer. Participants receive a 1-week course of oral antibiotics (amoxicillin, fosfomycin, and metronidazole) prior to transplantation. A single dose of donor-derived intestinal microbiota solution is administered via colonoscopy, followed by initiation of ICI-based therapy on the next day. The primary endpoint is the incidence of dose-limiting toxicity. Secondary endpoints include response rate, disease control rate, progression-free survival, overall survival, and adverse events. Comprehensive translational research is conducted using stool, blood, and tissue samples to characterize immune responses and identify biomarkers associated with A-FMT and ICI efficacy.

Indexed as

Anti-Bacterial AgentsEsophageal NeoplasmsFecal Microbiota TransplantationImmune Checkpoint InhibitorsImmunotherapyStomach NeoplasmsAdultAgedClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicFeasibility StudiesFemaleGastrointestinal MicrobiomeHumansMaleMiddle AgedAnti-Bacterial AgentsImmune Checkpoint InhibitorsAnti-programmed cell death 1 protein antibodyesophageal cancerfecal microbiota transplantationgastric cancerintestinal microbiota

Identifiers

PMID41403286
PMCPMC12758163

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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.