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

Completed

• Conditions: Liver cancer; Liver neoplasm; 10019815; 10027656; 10019818

• Registration Number: NL-OMON31730
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified