Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis

A Multicenter Study of Prognosis and the Efficacy Comparison of Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Patients(Clinical Risk Score≥3) of Resectable Colorectal Liver Metastasis

This study was designed to analyze the prognosis and recurrence predictive factors of high risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.

The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared for these patients.

Resection could prolong the survival of colorectal liver metastasis patients, however,the curative resection rate was still low and more than 2/3 of the patients would experience tumor recurrence.This study was designed to formulate a more accurate and individual evaluation system via the multivariate analysis.

Up to now, there was no data to demonstrate the addition of cetuximab to perioperative chemotherapy could decrease recurrence and prolong survival for RAS wild-type, high risk(Clinical Risk Score≥3) resectable colorectal liver metastasis patients. This study was also designed to elucidate this question and to observe the objective response rate(ORR) and the safety data of the regime.

Inclusion Criteria:

• good performance status
• pathologic diagnosis of colorectal cancer
• Rat sarcoma viral oncogene homolog(RAS) wild-type
• radiologic confirmation the resectability of liver metastases
• enough future liver remnant
• Clinical Risk Score≥3
• treatment naive
• extra-hepatic metastases could be resected completely, if exist

Exclusion Criteria:

• poor performance status, could not tolerate chemotherapy or operation
• other malignancy history or synchronously
• extra-hepatic metastases could not be resected completely, if exist
• received other treatment previously