A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer

Inclusion Criteria:

1. Age 18 or older.

2. Patients have newly diagnosed and previously untreated, histologically orradiologically confirmed hepatocellular carcinoma with at least one lesion that ismeasurable by RECIST 1.1 criteria. A prior HCC lesion that was treated surgically orby radiation is allowed as long as it was at least 2 years or more from the currentHCC diagnosis.

3. Patient's cancer must be deemed locally advanced and unresectable as per theconsensus of the Inova Multidisciplinary Cancer Care Conference.

4. Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not acandidate for aggressive systemic treatment.

5. Eastern Cooperative Oncology Group Performance Status of 0-2.

6. Patients must have adequate blood counts and organ function.

7. Memantine is harmful to the human fetus. For this reason, sexually active males withpartners of childbearing potential must agree to use an accepted and effectivemethod of contraception prior to study entry and for the duration of the study.Women of child bearing potential must have a negative serum pregnancy test resultwithin 24 hours prior to initiation of study treatment. They must also agree to useagree to use an accepted and effective method of contraception prior to study entryand for the duration of the study.

8. Patients must demonstrate ability to understand and the willingness to sign awritten informed consent document.

9. Men and women, regardless of race, ethnic group or sexual orientation are eligiblefor this study.

Exclusion Criteria:

1. Patients with Child-Pugh A cirrhosis.

2. Female patients who are pregnant or breast-feeding.

3. Concomitant illness or history that would prevent adequate patient assessment or inthe investigators' opinion pose an added risk for study participants.

4. Life-threatening intercurrent illness.

5. Anticipated poor compliance.

6. Subject is enrolled in a separate interventional clinical trial.

7. Active tuberculosis.

8. Significant cardiovascular disease (such as New York Heart Association Class II orgreater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstableangina.

9. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

10. Uncontrolled tumor-related pain. Patients requiring pain medication must be on astable regimen at study entry for at least 10 days prior to study entry.

11. Major surgical procedure, open biopsy, or significant traumatic injury within 28days prior to initiation of study treatment.

12. Symptomatic, untreated, or actively progressing central nervous system (CNS)metastases.

13. Patients undergoing other anti-cancer treatment. Palliative radiation for symptomcontrol will be allowed while on protocol.