Evidence map›Paper›PMID 40221699›Full record

Trial reportBMC cancer2025

A phase I/II trial evaluating the safety of increased-dose S- 1 with oxaliplatin and nivolumab in HER2-negative advanced gastric cancer.

Keisuke Baba, Nobumi Suzuki, Chiyo K Imamura, Eisuke Booka, Masashi Takeuchi, Daisuke Takahari, Takeshi Kawakami, Hirofumi Kawakubo, Chiyoe Kitagawa, Yoshiyasu Kono and 15 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

25 authors.

Keisuke BabaDepartment of Oncology and General Medicine, IMSUT Hospital, the Institute of Medical Science Hospital, the University of Tokyo, Tokyo, Japan.
Nobumi SuzukiDepartment of Gastroenterology Graduate School of Medicine, University of Tokyo, Tokyo, Japan.
Chiyo K ImamuraAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
Eisuke BookaDepartment of Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.
Masashi TakeuchiDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Daisuke TakahariDepartment of Gastroenterological Chemotherapy, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Takeshi KawakamiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Hirofumi KawakuboDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
Chiyoe KitagawaMedical Oncology and Respiratory Medicine, NHO Nagoya Medical Center, Aichi, Japan.
Yoshiyasu KonoDepartment of Gastroenterology and Hepatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.
Keiji OguraDepartment of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan.
Yosuke KitoDepartment of Medical Oncology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
Kei SaitoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.
Shinzo YamamotoDepartment of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan.
Hiroya TakeuchiDepartment of Surgery, Hamamatsu University School of Medicine, Shizuoka, Japan.
Toshihiro KudoDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
Takuya TsunodaDivision of Medical Oncology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Takuro MizukamiDepartment of Medical Oncology, NTT Medical Center Tokyo, Tokyo, Japan.
Toshifumi YamaguchiCancer Chemotherapy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
Hirokazu ShojiDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Kanako SaitoDepartment of Medical Oncology, Mie University Hospital, Mie, Japan.
Kenro TanoueDepartment of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Eishi BabaDepartment of Comprehensive Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kengo NagashimaBiostatistics Unit, Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.
Narikazu BokuDepartment of Oncology and General Medicine, IMSUT Hospital, the Institute of Medical Science Hospital, the University of Tokyo, Tokyo, Japan. nboku@ims.u-tokyo.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe developed and refined an S-1 dosage formula based on renal function, sex, and body surface area (BSA) to achieve the target area under the concentration-time curve of 5-fluorouracil in two prospective pharmacokinetic studies. The clinical validity of the refined formula (BBT formula) was evaluated using data from the two phase III trials of fist-line chemotherapy including S-1 for advanced gastric cancer, which demonstrated that overall survival and progression-free survival tended to be shorter in patients whose S-1 standard dose, based on BSA alone, was lower than that determined using the BBT formula.

methodsChemo-naïve patients with HER2-negative advanced gastric or gastroesophageal junction cancer, whose standard S-1 dose is lower than that determined using the BBT formula, receive S-1 at an increased dose based on the BBT formula plus oxaliplatin (130 mg/m DISCUSSION: This phase I/II trial evaluates the safety and efficacy of S-1 at increased doses, determined by the BBT formula, in combination with oxaliplatin and nivolumab in patients with HER2-negative advanced gastric cancer, whose standard dose of S- 1 is lower than the dose recommended dose by the BBT formula.

trial registrationThis study was approved by the University of Tokyo Clinical Research Review Board (URL: https://www.ut-crescent.jp/patients/chiken_jisshi/ , review number: 2022529SP) and was initiated at 19 institutions in June 2023 (registered as jRCTs031230127).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsOxonic AcidStomach NeoplasmsTegafurAdultAgedDrug CombinationsErb-b2 Receptor Tyrosine KinasesEsophagogastric JunctionFemaleHumansMaleMiddle AgedNivolumabOxaliplatinProgression-Free SurvivalDrug CombinationsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesNivolumabOxaliplatinOxonic AcidS 1 (combination)TegafurAdvanced gastric cancerDosage formulaNivolumabOxaliplatinS- 1

Identifiers

PMID40221699
PMCPMC11993961

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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.