60
Participants
Start Date
October 31, 2025
Primary Completion Date
October 31, 2026
Study Completion Date
April 30, 2027
standard second line treatment, at discretion of the investigator
Combination treatment may include: 5FU/LFA, capecitabine, oxaliplatin, irinotecan, bevacizumab, aflibercept
Regorafenib (BAY73-4506)
"Regorafenib will be administered following a dose-escalation strategy: starting dose 80 mg/day orally with weekly escalation, per 40 mg increment up to 160 mg/day regorafenib); if no significant drug-related adverse events occurred for 21 days of a 28-day cycle. The following cycle will be administered at highest tolerated dose from cycle 1 (up to 160 mg), as per current guidelines and clinical practice.~Treatment will continue until disease progression, unacceptable toxic effects, motivated decision to stop the treatment by the treating physician, or refusal or withdrawal of consent by the patient.~Every cycle will be administered every 28 days (four weeks) +/- 3 days."
National Cancer Institute, Naples
OTHER