mFOLFOXIRI+Bev vs. mFOLFOX6+Bev for RAS Mutant Unresectable Colorectal Liver-limited Metastases
Status:
Recruiting
Trial end date:
2026-03-30
Target enrollment:
Participant gender:
Summary
Colorectal cancer patients with initially unresectable liver-only metastases may be cured
after downsizing of metastases by conversion therapy. However, the optimal regimen of
conversion therapy for RAS mutant patients has not been defined.
In this study colorectal cancer patients with initially unresectable liver-only metastases,
as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined
criteria, will be tested for RAS and BRAF tumor mutation status. Patients with RAS mutant and
BRAF wild type will be randomised between modified FOLFOXIRI (mFOLFOXIRI) plus bevacizumab
and modified FOLFOX6 (mFOLFOX6) plus bevacizumab. Patient imaging will be reviewed for
resectability by MDT, consisting of at least one radiologist and three liver surgeons every
assessment. MDT review will be performed prior to randomization as well as during treatment,
as described in the protocol.