Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
Yanhong Deng , Lei Wang , Guanjian Liu , Huabin Hu , Yue Cai
Background: For liver limited metastatic colorectal cancers, complete resection of liver metastases is the only potentially curative treatment and can significantly improve overall survival. The current goal of medical treatment for colorectal cancer with initially unresectable liver metastases is to maximize the rate of secondary resection. This phase II study is to explore whether cetuximab in combination with FOLFOXIRI as first treatment could improve radical resectability in patients with KRAS/NRAS wild-type, unresectable liver - only metastases of colorectal cancer. Methods: The primary aim is to evaluate the percentage of patients who had a curative liver treatment following protocol treatment, i.e., liver metastases that can be completely resected and/or ablated with no evidence of residual malignant disease. Secondary aims include safty, objective response rate, overall survival, progression free survival, quality of life and an assessment of predictive molecular markers of response. 138 cases of patients met inclusion criteria and enrolled in the trial will be randomized to two therapy groups: experimental arm A (Chemotherapy with FOLFOXIRI + Cetuximab) or standard arm B (Chemotherapy with FOLFOXIRI). All patients will receive the study treatment regimen every 2 weeks, and a total of the maximum of 8 cycles. CT scan or MRI of the abdomen will be performed after 2 or 3 cycles of therapy to assess clinical response and resectability of liver metastases by multidisciplinary team including hepatic surgeon. If liver metastases are not deemed to be resectable at this assessment, but tumor assessment demonstrates stable disease or partial response, therapy will continue with re-assessment for clinical response and resectability after the next cycle. Clinical trial information: NCT02063529
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