OncoMatch/Clinical Trials/NCT04687631
Conversion Therapy of RAS/BRAF Wild-Type Colorectal Cancer Patients With Initially Unresectable Liver Metastases
Is NCT04687631 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including mFOLFOXIRI plus Cetuximab and mFOLFOXIRI Plus Bevacizumab for colorectal cancer.
Treatment: mFOLFOXIRI plus Cetuximab · mFOLFOXIRI Plus Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
RAS/BRAF gene wild-type states
Required: NRAS wild-type
RAS/BRAF gene wild-type states
Required: BRAF wild-type
RAS/BRAF gene wild-type states
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: targeted therapy
Patients with liver metastases from colorectal cancer who have previously received targeted therapy
Cannot have received: chemotherapy
Patients with liver metastases from colorectal cancer who have previously received chemotherapy
Cannot have received: radiotherapy
Patients with liver metastases from colorectal cancer who have previously received radiotherapy
Cannot have received: interventional therapy
Patients with liver metastases from colorectal cancer who have previously received interventional therapy
Lab requirements
Blood counts
neutrophil ≥ 1.5x10^9 / L and platelet count ≥ 100x10^9 / L; HB ≥ 9g / dl (within one week before randomization)
Kidney function
Normal kidney function (within one week before randomization)
Liver function
serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization)
Good hematological function: neutrophil ≥ 1.5x109 / L and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization); Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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