Cetuximab+mFOLFOX6 VS. mFOLFOX6 Alone in RAS/BRAF Wild Type Patients With High-Risk Resectable CRLM (NCT05948072) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Cetuximab+mFOLFOX6 VS. mFOLFOX6 Alone in RAS/BRAF Wild Type Patients With High-Risk Resectable CRLM
China250 participantsStarted 2023-07-15
Plain-language summary
For patients with initially resectable colorectal cancer liver metastases who have high-risk factors, neoadjuvant therapy is currently considered a consensus approach. However, there is ongoing debate regarding the optimal treatment strategy. Our study aims to investigate whether the addition of cetuximab to neoadjuvant chemotherapy improves outcomes compared to neoadjuvant chemotherapy alone. The objective of this phase III clinical trial is to determine whether the combination of cetuximab and mFOLFOX6 chemotherapy is superior to neoadjuvant mFOLFOX6 chemotherapy alone for patients with initially resectable colorectal cancer liver metastases who have wild-type RAS/BRAF and high-risk factors.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Histological proof of colorectal adenocarcinoma;
✓. Age ≥ 18 years and ≤75 years;
✓. RAS wild type；
✓. CRS≥3；
✓. Simultaneous liver-limited metastases;
✓. At least one measurable liver metastases;
✓. World Health Organization (WHO) performance status 0-1;
✓. Life expectancy ≥ 3 months;
Exclusion criteria
✕. Previous systemic treatment for metastatic disease;