- Trial ID:
- Catherine Frenette
- Prior diagnosis of HCC confirmed histologically.
- Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or adverse event(s)associated with prior systemic agent(s) that resulted in discontinuance of that agent(s).
- Cirrhotic status of Child-Pugh grade B7.
- Expected survival of at least 3 months.
- Adequate hematologic, hepatic, and renal function.
- Candidate for potential curative therapies (i.e., resection or transplantation) or loco-regional approaches (i.e., ablation, embolization).
- Significant cardiac disease.
- Serious infection requiring treatment with systemically administered antibiotics.
- Pregnancy or lactation.
- Expected non-compliance.
- Uncontrolled intercurrent illness, or psychiatric illness or social situations that would limit compliance with study requirements.
- Subjects who have had any anticancer treatment within 2 weeks prior to entering the study.
- Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies.
- Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.
- Allergy to pegylated products.
- Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.
- Subjects known to be HIV positive.
- Uncontrolled ascites (defined as not easily controlled with diuretic treatment).
- Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until first dose of study drug or placebo.
- Use of traditional medicines approved by local authorities, including but not limited to Chinese herbs within 14 days of first dose of study drug or placebo.
- ECOG performance status > 2.
- Prior allograft,including liver transplant.
- John S Bomalaski, M.D.
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
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