A Phase I safety, toxicity and biomarker study of peri-operative sorafenib treatment in patients undergoing radiofrequency ablation (RFA) for liver metastases of colorectal cancer - Peri-ablative Sorafenib in patients with CRLM

niversitair Medisch Centrum Utrecht0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年8月12日

适应症

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•1. Patients that have signed written informed consent
•2. Patients undergoing percutaneous or laparascopic radiofrequency ablation for colorectal liver metastases, i.e., patients with metastases limited to the liver that are not surgically resectable.
•3. Patients of whom their largest liver metastasis does not exceed 4 cm.
•4. Patients with metastases that are not adjacent to or incorporated in one of the large vessels or biliary tract
•5. Patients with metastases > 1 cm distance from the liver hilus.
•6. Patients with 3 metastases or less
•7. Age > 18 years.
•8. ECOG Performance Status of 0 tm 2.
•9. Life expectancy of at least 12 weeks.
•10. Subjects with at least one uni-dimensional(for RECIST) or bi-dimensional (for WHO) measurable lesion. Lesions must be measured by CT-scan or MRI
•11. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
•12. No concurrent chemotherapy or other anti-tumour therapies.

•1. Extrahepatic metastases
•2. WHO performance status > 2
•3. Patients undergoing open RFA
•4. Patients should not have more than 3 metastases
•5. Largest lesion should not exceed 4 cm
•6. Patients should not have any tumour adjacent to or incorporated in one of the large vessels or bile structures
•7. Patients should not have any tumor situated in less than 1 cm of the liver hilus.

发起方

niversitair Medisch Centrum Utrecht