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Study of Pegylated Human Recombinant Arginase for Liver Cancer

NCT00988195 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-03-14

No results posted yet for this study

Summary

The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).

Conditions

Interventions

BIOLOGICAL

Pegylated Recombinant Human Arginase I

Week 1 (Single Dose); Weeks 3 - 11 (Weekly Dose x 8 weeks)in 8 escalation doses

DRUG

Doxorubicin

Weeks 13-24 (once every 3 weeks)

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER

  • Chinese University of Hong Kong

    collaborator OTHER

  • Bio-Cancer Treatment International Limited

    lead INDUSTRY

Principal Investigators

  • Ronnie TP Poon, Prof · Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988195 on ClinicalTrials.gov