OncoMatch/Clinical Trials/NCT04776655
Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB
Is NCT04776655 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for colorectal cancer.
Treatment: Bevacizumab · Cetuximab · 5-FU · Irinotecan · Calcium levofolinate — This study is a prospective, randomized phase III, to evaluate if in patients with mCRC RAS/BRAF wild type on tumor tissue and RAS mutations on liquid biopsy, treating in first line with antibody anti-VEGF (bevacizumab) plus chemotherapy (FOLFIRI) is superior in terms of PFS compared to standard treatment with antibody anti-EGFR (cetuximab) plus FOLFIRI, and then in patients RAS/BRAF wild type on tumor tissue who develop RAS mutations on liquid biopsy after the beginning of the first line treatment with cetuximab plus FOLFIRI, in the absence of a clinical or radiological progression disease, to anticipate a change of treatment with bevacizumab plus FOLFIRI further impacts on the PFS.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
RAS/BRAF wild type (analysed either on primary and/or related metastasis)
Required: NRAS wild-type
RAS/BRAF wild type (analysed either on primary and/or related metastasis)
Required: BRAF wild-type
RAS/BRAF wild type (analysed either on primary and/or related metastasis)
Required: DPYD wild-type
If DPD status is known it must be wild type. No restrictions are applied if DPD status in unknown
Disease stage
Metastatic disease required
Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease; At least one site of measurable disease per RECIST criteria ver. 1.1
Performance status
ECOG 2–2(Ambulatory, capable of self-care)
ECOG Performance status = 2
Prior therapy
Cannot have received: chemotherapy
Exception: adjuvant setting completed at least 6 months before randomization
Previous chemotherapy treatment, with the exception of patient treated in adjuvant setting completed at least 6 months before the randomization
Cannot have received: radiation therapy
Radiotherapy to any site within 4 weeks before the randomization
Lab requirements
Blood counts
Adequate bone marrow function assessed before starting study treatment
Kidney function
Adequate renal function assessed before starting study treatment
Liver function
Adequate liver function assessed before starting study treatment
Adequate bone marrow, liver and renal function assessed before starting study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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