NL-OMON32387
Withdrawn
Phase 2
Identification of predictive factors for response to neo-adjuvant Sunitinib in patients with resectable hepatocellular carcinoma - Predictive factors of response to Sunitinib in HCC.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- hepatocellular carcinoma
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 15
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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