Treatment of Non-Metastatic Hepatocellular Carcinoma in Humans by Increasing Gabaergic Activity: A Pilot Study
A total of 47 consecutive patients with radiologic or histologic evidence of non metastatic
liver cancer will be enrolled over a 2-4 year period. Subjects will receive oral Baclofen
at the manufacturer's suggested maximal dose. Clinical, hematologic, biochemical, and
radiologic features of liver function, tumor metastasis and recurrence will be monitored at
regular time intervals over a 2 year treatment period. The primary study end point will be
the event of interest (time to metastasis or recurrence). Secondary end points will include
time to metastasis following recurrence, objective tumor responses (complete, partial and
non response), response duration, survival and safety. It is hoped the results of this
study will permit liver cancer patients to remain candidates for surgical resection and
transplantation longer than would otherwise have been the case.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Document and Compare the effects of the GABAb receptor agonist Baclofen on the time to develop tumor metastasis in patients with non-metastatic HCC at diagnosis who subsequently undergo surgical resection, ablation or chemoembolization.
Minuk Y Minuk, MD, FRCPC
University of Manitoba
Canada: Health Canada