NCT06007846 · Inova Health Care Services
A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
What this study is about
This is a single-site forward-looking study to describe effectiveness endpoints of single agent memantine in patients with unresectable, locally advanced, or metastatic HCC otherwise not deemed candidates for intensive systemic therapy. In addition to the primary goal measurement and multiple secondary effectiveness endpoints, we will describe changes in quality of life on treatment over time.
View original scientific description
This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, or metastatic HCC otherwise not deemed candidates for intensive systemic therapy. In addition to the primary endpoint and multiple secondary efficacy endpoints, we will describe changes in quality of life on treatment over time.
Interventions
DRUG
Namenda
Memantine 5 mg by mouth once daily, to be titrated up to 20 mg daily
Primary outcome measures
Patients Progression Free Survival at 6 months
Time frame: 6 months from the start of treatment
The response and progression will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. The progression of the disease is defined as at least a 20% increase in the sum of the Longest Diameter LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions or death due to disease without objective evidence of progression.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 or older. 2. Patients have newly diagnosed and previously untreated, histologically or radiologically confirmed hepatocellular carcinoma with at least one lesion that is measurable by RECIST 1.1 criteria. A prior HCC lesion that was treated surgically or by radiation is allowed as long as it was at least 2 years or more from the current HCC diagnosis. 3. Patient's cancer must be deemed locally advanced and unresectable as per the consensus of the Inova Multidisciplinary Cancer Care Conference. 4. Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a candidate 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 with partners of childbearing potential must agree to use an accepted and effective method of contraception prior to study entry
Where
- Fairfax, Virginia
- Falls Church, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2025 · Source of record for eligibility and locations