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Investigator(s):
Tim F. Greten, M.D. Principal Investigator Phone: 301-451-4723 Fax: 301-480-8780 gretentf@mail.nih.gov	Austin G. Duffy, M.D. Co-Investigator Phone: 301-451-8340 Fax: 301-480-8780 duffya@mail.nih.gov
Referral Contact(s):
Suzanne Fioravanti, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-6544 Fax: 301-480-2590 fioravas@mail.nih.gov

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Key Eligibility Criteria:

• Histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC)
• Childs-Pugh A or B (7 points) cirrhosis is allowed
• Disease that is not amenable to potentially curative resection, radiofrequency ablation, or liver transplantation
• In Phase I, prior systemic therapy is allowed; patients who received prior sorafenib must not have required a dose-reduction for toxicity
• In Phase II, prior systemic therapy for HCC (including sorafenib) is not allowed
• No history of bleeding varices within one year
• Endoscopic evaluation within 6 months of starting the study
• No anti-coagulation (except low-dose aspirin)

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Study Outline:

• Screening with a physical examination, medical history, imaging studies, and tests to verify eligibility for the study
• Sorafenib taken by mouth twice a day, every day
• TRC105 intravenously (IV) in a vein every two weeks
• This schedule will be repeated every 4 weeks (1 cycle)
• Cycles repeat in the absence of disease progression or unacceptable side effects
• Imaging studies to assess for response and progression every 8 weeks

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/12/12
Updated: 9/12/12