Identification of predictive factors for response to neo-adjuvant Sunitinib in patients with resectable hepatocellular carcinoma

Phase 2

Withdrawn

Conditions: hepatocellular carcinoma
liver cancer
10019815
10019818

Registration Number: NL-OMON32387

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

-Histologically proven and documented hepatocellular carcinoma of the liver
-Liver-only HCC eligible for RFA and/or resection
-Age >= 18
-WHO performance status 0-2
- Adequate bone marrow, liver and renal functions
-Written, voluntary informed consent
-Patients must be accessible to follow up and management in the treatment centre
-Patients must sufficiently understand the Dutch language and must be able to sign the informed consent document.
-A life expectancy of at least 3 months.

Exclusion Criteria

-Extrahepatic metastases or intrahepatic metastasis not eligible for RFA/resection
-CHILD C liver cirrhosis
-Patients with evidence or a history of bleeding diathesis
-Clinically significant cardiovascular disease
-Evidence of serious active infections
-Prior chemotherapy or biological therapy for metastatic disease.
-Prior radiotherapy on the involved area.
-Major surgery within 28 days before the initiation of the study.
-Dementia or altered mental status that would prohibit the understanding and giving of informed consent
-Pregnant or lactating women. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with sunitinib.
-CNS metastases (CT-Scan not mandatory)
-Treatment with any investigational drug within 30 days before the start of the study
-Prior allergic reaction to immunoglobulins or immunoglobulin allergy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>to determine changes (tissue/serum biomarkers) in familiar pathways of<br /><br>hepatocellular cancer (HCC) to sunitinib treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-to correlate the changes in these pathways to FDG-PET scan and 111In-<br /><br>bevacizumab scan results before and after sunitinib treatment<br /><br>-to assess the safety and toxicity of pre-surgery sunitinib in patients with<br /><br>liver-only HCC</p><br>