| Official Title |
Recombinant Human Arginase I (rhArgI) for Patients with Advanced Hepatocellular Carcinoma (HCC): An Adaptive Design Dose Escalation Trial with Addition of Standard Doxorubicin Treatment |
| Countries |
Hong Kong |
| Study Arm |
All Patients will receive PEG-BCT-100B in a weekly base first 10 weeks in part one. A CT scan will be performed in week 11, those have stable disease will then proceed to part two of the trial. In part two, PEG-BCT-100B will be given in a weekly base plus Doxorubicin in a 3-week cycle. |
| Description |
HCC is an aggressive, largely chemo-resistant cancer with a poor prognosis, currently there is no effective systemic chemotherapy for HCC. HCC and some other cancers (e.g. melanoma) requires arginine for growth because of the lack of the enzymes to convert other amino acids to arginine. The effect of arginine depletion on tumor growth has been documented.
This study aims to evaluate To evaluate the safety and efficacy of repeated doses of PEG-BCT-100B for patients with advanced HCC |
| Age Eligible for study |
18 - 75 years |
| Genders Eligible for Study |
Both |
| Key Inclusion Criteria |
- Diagnosed hepatocellular carcinoma (HCC)
- Have preserved liver function
- Karnofsky performance state more than 80%
|
| Key Exclusion Criteria |
- Patients with ascites uncontrolled by medication
- Prior treatment with Arginase depleting agent
- Use of investigational drug(s) within 4 weeks of enrollment
|
