Metastatic Colorectal Cancer Clinical Trial
Official title:
A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer
The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of resectable liver metastases from colorectal cancer.
The Primary Endpoint of this study is Tumour resectability at surgery. Secondary Endpoints: 1. Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0) 2. Tumour response assessed by imaging (RECIST and necrosis) 3. Viable residual tumour assessed by pathological evaluation of resected liver tissue. 4. Recurrence (time and site) following resection 5. Correlation of tumour response by imaging and pathology ;
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|---|---|---|---|
| Completed |
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