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

niversitair Medisch Centrum Groningen0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•-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.

•-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

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