Future oncology (London, England) · 2023
Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers with stable disease (ICONIC).
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Cavalieri Stefano, Vitolo Viviana, Barcellini Amelia, Ronchi Sara, Facoetti Angelica, Campo Chiara, Klersy Catherine, Molinelli Silvia, Agustoni Francesco, Ferretti Virginia Valeria, Silvestri Annalisa De, Platania Marco, Del Vecchio Michele, Durante Marco, Helm Alexander, Fournier Claudia, Braud Filippo de, Pedrazzoli Paolo, Orlandi Ester, Licitra Lisa
Аннотация
ICONIC is a multicenter, open-label, nonrandomized phase II clinical trial aiming to assess the feasibility and clinical activity of the addition of carbon ion radiotherapy to immune checkpoint inhibitors in cancer patients who have obtained disease stability with pembrolizumab administered as per standard-of-care. The primary end point is objective response rate, and the secondary end points are safety, survival and disease control rate. Translational research is an exploratory aim. The planned sample size is 27 patients. The study combination will be considered worth investigating if at least four objective responses are observed. If the null hypothesis is rejected, ICONIC will be the first proof of concept of the feasibility and clinical activity of the addition of carbon ion radiotherapy to immune checkpoint inhibitors in oncology.