Open-label, Uncontrolled, Multi-center, Phase II Study of Cetuximab in Combination With mFOLFOX-6 as First-line Treatment in Patients With KRAS Wild-type, Unresectable LIver Metastases of colorEctal Cancer
During the last decade, chemotherapy in metastatic colorectal cancer (mCRC) has made
considerable progress.However, approximately 25% of patients with colorectal cancer present
with overt metastatic disease. In selected patients, synchronous or metachronous liver
metastases (LM) can be resected in curative intention. Over the last 5 years there has been
the recognition that preoperative, neoadjuvant, combination chemotherapy regimens, namely,
5-fluorouracil/folinic acid (5-FU/FA) in combination with either irinotecan or oxaliplatin
can facilitate to downsize the initially unresectable LM and make the resection possible.
The addition of targeted therapies might render them even more effective.
Due to these results, the investigators hypothesize that cetuximab in combination with
mFOLFOX6 as treatment in patients with KRAS wild-type, unresectable liver metastases of mCRC
may further improve clinical outcomes.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Resection rate (R0)
from the first cycle of treatment (day one) to two month after the last cycle
Sanjun Cai, PhD
China: Ethics Committee