OncoMatch/Clinical Trials/NCT04781270
mFOLFOXIRI+Bev vs. mFOLFOX6+Bev for RAS Mutant Unresectable Colorectal Liver-limited Metastases
Is NCT04781270 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including mFOLFOXIRI regimen and mFOLFOX regimen for colorectal carcinoma.
Treatment: mFOLFOXIRI regimen · mFOLFOX regimen · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: BRAF wild-type
Required: KRAS mutation
Required: NRAS mutation
Disease stage
Metastatic disease required
Performance status
WHO 0–1
Prior therapy
Cannot have received: systemic therapy
Previous systemic treatment for metastatic disease
Cannot have received: surgery for metastatic disease
Previous surgery for metastatic disease
Lab requirements
Blood counts
absolute neutrophil count (ANC)≥1.5×10^9/l, platelets≥100×10^9/l, and hemoglobin(HB) ≥ 9g/dl
Kidney function
serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min
Liver function
total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal (ULN)
Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×10^9/l, platelets≥100×10^9/l, and hemoglobin(HB) ≥ 9g/dl; Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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