Conversion Therapy of RAS/BRAF Wild-Type Colorectal Cancer Patients With Initially Unresectable Liver Metastases
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Evidence suggests that the addition of cetuximab or bevacizumab to doublet regimens could
improve response rate and resectability rate of liver metastases and survival in colorectal
liver metastases (CRLM). Moreover, it is observed that FOLFOXIRI yields higher response and
resection rates compared with doublet regimens. However, which is better in conversion
therapy of RAS/BRAF wild-type initially unresectable CRLM, FOLFOXIRI plus cetuximab or
bevacizumab, remains unknown.
In this study, RAS/BRAF wild-type colorectal cancer patients with initially unresectable
liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT)
according to predefined criteria, will be randomised between modified FOLFOXIRI (mFOLFOXIRI)
plus cetuximab and mFOLFOXIRI 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.