Study protocol of a randomized controlled phase II trial comparing nivolumab, ipilimumab plus radiotherapy versus nivolumab plus ipilimumab for advanced or recurrent esophageal cancer: Japan Clinical Oncology Group study JCOG2311 (ART NOUVEAU)
Rattachement africain : jp, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: The immunogenic cell death induced by radiotherapy (RT) has been demonstrated to enhance the systemic antitumor effect of immune checkpoint inhibitors (ICIs). The incorporation of RT into ICIs has the potential to mitigate the occurrence of early treatment failure, particularly with dual ICI combination, in patients with advanced or recurrent esophageal cancer. METHODS: This randomized phase II trial, initiated in November 2024, aims to explore the superiority of the combination of RT with nivolumab plus ipilimumab over nivolumab plus ipilimumab alone in patients with advanced or recurrent esophageal squamous cell carcinoma. The primary endpoint is progression-free survival, while the secondary endpoints include overall survival, response rate, duration of response, and adverse events. We assumed a 6-month PFS of 35% in the nivolumab plus ipilimumab alone arm and expected a 15% increase in the 6-month PFS for the RT with nivolumab plus ipilimumab arm (HR, 0.66). The total required sample size was calculated to be 70 (35 per arm) to achieve a desired power of 80% with an overall one-sided alpha of 20%, an accrual period of 2.5 years, and a follow-up period of 1 year. A total of 74 patients will be enrolled from 41 institutions in Japan. An ancillary study analyzes cytokine profiles and phenotypic characteristics in peripheral blood mononuclear cells during treatment with the protocol. DISCUSSION: The objective of this trial is to assess the safety and efficacy of RT in combination with dual ICIs in reducing early treatment failure and improving outcomes with translational research. Findings from this trial will inform a future phase III trial in this patient population. TRIAL REGISTRATION: This trial has been registered on November 5th, 2024, in the Japan Registry of Clinical Trials as jRCT1031240461 ( https://jrct.mhlw.go.jp/en-latest-detail/jRCT1031240461 ).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Study protocol of a randomized controlled phase II trial comparing nivolumab, ipilimumab plus radiotherapy versus nivolumab plus ipilimumab for advanced or recurrent esophageal cancer: Japan Clinical Oncology Group study JCOG2311 (ART NOUVEAU)
- Date Crossref
- 03/12/2025
- 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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Kyoto University pays non établi dans la noticeUniversité ou école supérieure
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Japan Clinical Cancer Research Organization pays non établi dans la noticeStructure de recherche
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Shizuoka Cancer Center pays non établi dans la noticeOrganisme public
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Hiroshima University Department of Surgical Oncology pays non établi dans la noticeUniversité ou école supérieure
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Kitasato University 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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National Cancer Center Department Head and Neck pays non établi dans la noticeOrganisation à but non lucratif
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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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Graduate School of Medicine Department of Radiation Oncology and Image-Applied Therapy pays non établi dans la noticeUniversité ou école supérieure
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Japan Clinical Oncology Group Data Center/Operations Office pays non établi dans la noticeÉtablissement de santé
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Division of Gastrointestinal Oncology pays non établi dans la noticeInstitution
Kyoto University, Japan Clinical Cancer Research Organization et Shizuoka Cancer Center, avec 8 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.