Study of Memantine Treatment in Adults With Advanced Liver Cirrhosis and Liver Cancer Not Suitable for Intensive Therapy
Led by Inova Health Care Services · Updated on 2025-09-30
12
Participants Needed
2
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of memantine, a single drug, in patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma HCC who also have cirrhosis and are not candidates for intensive systemic therapy. This prospective study aims to describe the drugs effects on disease progression and quality of life over time. The study is sponsored by Inova Health Care Services and focuses on patients with a Child-Pugh cirrhosis score of B7 or higher and an Eastern Cooperative Oncology Group performance status of 0-2.
Participants will receive memantine starting at 5 mg by mouth once daily, with doses increased up to 20 mg daily as tolerated. The study is conducted at a single site and follows patients through treatment to assess efficacy endpoints, including progression-free survival at 6 months. The treatment plan excludes aggressive systemic therapies and allows palliative radiation for symptom control.
During the study, participants will be monitored for disease progression and quality of life changes. Assessments include measuring tumor lesions by RECIST 1.1 criteria and ensuring adequate blood counts and organ function. Safety is closely observed, especially regarding pregnancy risks, cardiovascular health, and other medical conditions. The study continues until August 31, 2026, with ongoing evaluations at defined intervals.
CONDITIONS
Brief Title
A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
Research Team
E
Elahe Mollapour
K
Keary Jane't
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Memantine Treatment (Clinical Trial)
Best Supportive Care (Current Guideline Recommendation)
What is it?
Memantine is an oral medication typically used for dementia, being evaluated here for its potential effects in patients with advanced, unresectable hepatocellular carcinoma and high-risk Child-Pugh B cirrhosis. Participants receive memantine tablets daily, titrating from 5 mg up to 20 mg per protocol.
Supportive care includes symptom management, nutrition, pain control, hydration, and ongoing palliative interventions. Systemic therapies are generally not indicated for patients with advanced HCC and Child-Pugh B7+ cirrhosis, according to the latest guidelines.
Primary use
Investigational use of memantine aims to explore progression-free survival and safety in patients with advanced, unresectable liver cancer and high-risk cirrhosis who cannot tolerate aggressive treatment.
Best supportive care is intended to maximize comfort, alleviate symptoms, and maintain quality of life for patients with advanced HCC and decompensated cirrhosis who are not candidates for disease-modifying therapy.
How is it given or performed?
Participants take memantine orally, starting at 5 mg daily and increasing to 20 mg daily as tolerated. Study visits monitor adherence and response.
Supportive care involves multidisciplinary management, including symptom-directed therapies, medication for pain and fluid balance, and palliative measures tailored to patient needs. No disease-targeting drug is administered.
Evidence status
Efficacy of memantine in this specific patient population is not yet established; the trial is ongoing and no published results are available.
Supportive care is recognized in guidelines as the best available approach for this population, but does not modify disease progression in advanced HCC with severe cirrhosis.
Important limitations
Potential risks include unknown safety profile in patients with advanced cirrhosis and HCC, uncertain effectiveness, and limited prior research in this disease context. Small sample size may restrict generalizability.
Supportive care does not halt disease progression or prolong survival; symptom management may be limited by organ dysfunction and lack of disease-directed treatments.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age 18 or older
Newly diagnosed and previously untreated hepatocellular carcinoma confirmed by histology or imaging with at least one measurable lesion
Locally advanced and unresectable cancer as determined by a multidisciplinary cancer care conference
Child-Pugh cirrhosis score of B7 or greater
Eastern Cooperative Oncology Group Performance Status of 0 to 2
Adequate blood counts and organ function
Use of effective contraception for sexually active males with partners of childbearing potential and women of childbearing potential with negative pregnancy test
Ability to understand and willingness to sign informed consent
Men and women of all races, ethnic groups, and sexual orientations
You will not qualify if you...
Patients with Child-Pugh A cirrhosis
Pregnant or breastfeeding women
Illness or history preventing adequate assessment or posing added risk
Life-threatening intercurrent illness
Poor expected compliance
Enrollment in another interventional clinical trial
Active tuberculosis
Significant cardiovascular disease within 3 months before treatment
Known fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma and HCC
Uncontrolled tumor-related pain without stable pain medication for at least 10 days
Major surgery, open biopsy, or major injury within 28 days before treatment
Untreated or progressing central nervous system metastases
Receiving other anti-cancer treatments except allowed palliative radiation for symptom control
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months from the start of treatment
Participants take Memantine by mouth, starting at 5 mg once daily and titrated up to 20 mg daily to treat liver cancer and cirrhosis.
Regular visits for medication titration and monitoring
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Development of a questionnaire module to supplement the EORTC QLQ-C30 to assess quality of life in patients with hepatocellular carcinoma, the EORTC QLQ-HCC18.
Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer. EORTC Study Group on Quality of Life.
Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial.