OncoMatch/Clinical Trials/NCT05022030
First-line mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for Metastatic Left-sided CRC With Wild-type RAS/BRAF Genes
Is NCT05022030 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including mCapOX plus cetuximab and mFOLFOX6 plus cetuximab for colo-rectal cancer.
Treatment: mCapOX plus cetuximab · mFOLFOX6 plus cetuximab — This prospective, randomized, phase 2 study is conducted to evaluate the efficacy and safety of first line mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS and BRAF genes.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
wild-type RAS and BRAF genes
Required: NRAS wild-type
wild-type RAS and BRAF genes
Required: BRAF wild-type
wild-type RAS and BRAF genes
Excluded: MSH2 deficient
Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
Excluded: MSH6 deficient
Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
Excluded: MLH1 deficient
Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
Excluded: PMS2 deficient
Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy containing oxaliplatin and fluorouracil
Exception: adjuvant chemotherapy completed more than 12 months before study entry is allowed
Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study
Cannot have received: palliative chemotherapy, targeted therapy, immunotherapy, or prior platinum-based adjuvant chemotherapy
No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy
Cannot have received: palliative chemotherapy
Patients who have failed one or more palliative chemotherapy regimens
Lab requirements
Blood counts
neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 75 × 10^9/L, hemoglobin ≥ 8 g/dL
Kidney function
creatinine clearance (Cockcroft and Gault) > 50 mL/min or serum creatinine ≤ 1.5 × UNL
Liver function
total bilirubin ≤ 1.5 × upper limit of normal (UNL); ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH < 1500 U/L
Requirements for lab indicators neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 75 × 10^9/L, hemoglobin ≥ 8 g/dL, total bilirubin ≤ 1.5 × UNL; ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH < 1500 U/L; creatinine clearance (Cockcroft and Gault) > 50 mL/min or serum creatinine ≤ 1.5 × UNL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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