A phase I/II trial evaluating the safety of increased-dose S- 1 with oxaliplatin and nivolumab in HER2-negative advanced gastric cancer
Rattachement africain : jp. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: We 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. METHODS: ) and nivolumab (360 mg/body). The primary endpoint is the incidence of dose-limiting toxicity in six patients in the phase I part and the proportion of patients requiring S-1 dose reduction in a total of 20 patients, expecting 30% and rejecting 50% with an alpha error of 0.1 and beta error of 0.2. The secondary endpoints are adverse events, relative dose intensity, response rate, disease control rate, progression-free survival, and overall survival. A correlation study is conducted to investigate the immune profiles associated with efficacy. 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 REGISTRATION: This 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).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- A phase I/II trial evaluating the safety of increased-dose S- 1 with oxaliplatin and nivolumab in HER2-negative advanced gastric cancer
- Date Crossref
- 12/04/2025
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Tokyo Hospital pays non établi dans la noticeÉtablissement de santé
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The University of Tokyo Department of Oncology and General Medicine pays non établi dans la noticeUniversité ou école supérieure
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SHOWA Medical University pays non établi dans la noticeUniversité ou école supérieure
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Hamamatsu University School of Medicine Department of Surgery pays non établi dans la noticeUniversité ou école supérieure
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Keio University Department of Surgery pays non établi dans la noticeUniversité ou école supérieure
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The Cancer Institute Hospital Department of Gastroenterological Chemotherapy pays non établi dans la noticeÉtablissement de santé
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Japanese Foundation For Cancer Research pays non établi dans la noticeOrganisation à but non lucratif
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Shizuoka Cancer Center pays non établi dans la noticeOrganisme public
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Nagoya Medical Center Medical Oncology and Respiratory Medicine pays non établi dans la noticeÉtablissement de santé
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Okayama University Department of Gastroenterology and Hepatology pays non établi dans la noticeUniversité ou école supérieure
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Tokyo Metropolitan Police Hospital Department of Gastroenterology pays non établi dans la noticeÉtablissement de santé
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Ishikawa Prefectural Central Hospital Department of Medical Oncology pays non établi dans la noticeÉtablissement de santé
University of Tokyo Hospital, Department of Oncology and General Medicine — The University of Tokyo et SHOWA Medical University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.