Know Cancer

forgot password

Treatment of Non-Metastatic Hepatocellular Carcinoma in Humans by Increasing Gabaergic Activity: A Pilot Study

Phase 2
18 Years
70 Years
Not Enrolling
Hepatocellular Carcinoma

Thank you

Trial Information

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.

Inclusion Criteria:

- A diagnosis of HCC and no evidence of extra-hepatic metastases on CT/MRI scan of the
abdomen, CT of the chest and brain and a negative bone scan.

- Patients undergoing local therapy (resection, ablation or chemoembolization) and
those listed for liver transplantation will not be excluded from participating in the

- Patients with multiple space occupying lesions within the liver (but no evidence of
extra-hepatic metastases) will continue to be eligible (the distinction between
regenerative nodules and multi-focal HCC versus intra-hepatic metastases can not be
made with certainty by presently available techniques).

- Karnofsky Performance Status (KPS) ≥ 60 %.

- Age 18 years or greater.

- Life expectancy of at least 12 weeks.

- Concomitant Medications

- Patients should be on stable doses of other medications (no change in dose for two
weeks prior to study initiation) when entered into the study.

- Patient consent must be obtained from all patients prior to entry into the trial.

- Patients must be accessible for treatment and follow-up i.e. residing within
reasonable geographical limits of the study site.

Exclusion Criteria:

- Any investigational agent within a minimum of 6 weeks prior to study treatment.

- Pregnant or lactating women; women or men of childbearing potential unless using
effective contraception. Patients capable of reproduction must agree to use
appropriate methods of contraception during the study and for six months afterwards.
Female patients of childbearing potential must have a negative urine pregnancy test
within 14 days of study enrollment.

- Patients whose partners are pregnant.

- Other serious illness or medical conditions which would not permit the patient to be
managed according to the protocol including:

- History of a psychiatric disorder which would impair the ability to obtain
consent or follow-up tumor imaging.

- Active uncontrolled infection.

- Any known defect in GABA metabolism or hypersensitivity to Baclofen.

- Patients with previous organ allograft or taking immunomodulatory drugs.

- Renal failure not being managed by dialysis.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

6 years

Safety Issue:


Principal Investigator

Minuk Y Minuk, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Manitoba


Canada: Health Canada

Study ID:




Start Date:

July 2007

Completion Date:

July 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • GABAergic Activity
  • Baclofen
  • Carcinoma
  • Carcinoma, Hepatocellular