Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT00966251
Recruitment Status :
(The study was stopped because of slow accrual)
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects aged 18 years and above, both genders.
Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)
No fibrolamellar subtype HCC
Not eligible for any other systemic anti-neoplastic treatment approved for HCC
Not eligible for Transarterial chemoembolization (TACE ).
No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA) that were used for HCC, are permitted.
Not a candidate for curative surgical resection or liver transplantation
Measurable disease defined by the identification at least 1 measurable lesion by MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging post-procedure to be considered measurable disease.
Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)
Child's Pugh classification A
ECOG performance status 0-1
Patients progressing to liver failure.
No core biopsy within the past 7 days
Patients who are eligible for Transarterial Chemoembolization (TACE)
Patients on concurrent anti-neoplastic therapy (including interferon)
Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.
Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids