110
Participants
Start Date
October 31, 2025
Primary Completion Date
October 31, 2027
Study Completion Date
October 31, 2027
Silibinin as STAT3 inhibitor
Sillbrain will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Each 3.7 g sachet of Sillbrain contains 500 mg silibinin. Every patient will assume 2 sachets/day for a total of 1 g/day of silibinin.
Placebo
Placebo will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Every patient will assume 2 sachets/day for a total of 1 g/day of placebo.
Humanitas Cancer Center, Milan
IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan
Ospedale A. Manzoni Lecco, Lecco
Istituto Neurologico Nazionale a Carattere Scientifico IRCCS - Fondazione Mondino, Pavia
Istituto Oncologico Veneto, Padua
IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna
IRST Dino Amadori, Meldola
Azienda Ospedaliera Universitaria - Careggi, Florence
USL Nord Ovest Toscana - Livorno, Livorno
Ospedale del Mare, ASL Napoli1 Centro, Napoli
"Azienda Ospedaliero Universitaria Policlinico G. Rodolico - San Marco ", Catania
Azienda Ospedaliera Universitaria G.Martino, Messina
ARNAS G.Brotzu P.O Armando Businco, Cagliari
Istituto Tumori Regina Elena IRCCS, Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma
Policlinico San Martino - Genova, Genova
Istituto Oncologico Veneto IRCCS
OTHER