Recombinant Human Arginase I (rhArgI) for Patients With Advanced Hepatocellular Carcinoma (HCC)
The primary objectives of this study are:
- To evaluate any objective tumor responses to PEG-BCT-100 in HCC patients receiving
weekly doses of PEG-BCT-100 alone.
- To perform PK and PD analysis
- To measure Quality of Life of the patients
Secondary objectives of this study are:
- To define any toxicity associated with the metabolic and cellular alterations of ADD
relative to dose and PK of PEG-BCT-100 (rhArgIpeg5000).
- To confirm the safety and anti-tumor activity of PEG-BCT-100 at the preferred dose
(1600U/kg) in 50 patients (at least 18 evaluable subjects) with advanced HCC.
- To measure duration of response including Overall Survival and Time to Progression
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response endpoints include(a)Objective response for each patient evaluated by RECIST, (b)Modified RECIST criteria will be used as secondary reference, (c) The proportion of patients achieving a partial response or complete response (d) The proportion of patients reporting disease progression by RECIST and the times to progression (e)Serial changes in plasma AFP levels after doses of PEG-BCT-100 and (f)Change in relevant viral serology from baseline to end-of-study
Ronnie TP Poon, Prof
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong
Hong Kong: Department of Health