Actively Recruiting
A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
Led by Inova Health Care Services · Updated on 2025-09-30
12
Participants Needed
2
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
Who Can Participate
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, unresectable cancer as determined by a multidisciplinary cancer care conference
- Child-Pugh cirrhosis score of B7 or greater and not candidates for aggressive systemic treatment
- 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 a negative pregnancy test within 24 hours before treatment
- Ability to understand and willingness to sign informed consent
- Men and women of any race, ethnicity, or sexual orientation
You will not qualify if you...
- Patients with Child-Pugh A cirrhosis
- Female patients who are pregnant or breastfeeding
- Concomitant illness or history that prevents adequate assessment or poses added risk
- Life-threatening intercurrent illness
- Anticipated poor compliance
- Enrollment in another interventional clinical trial
- Active tuberculosis
- Significant cardiovascular disease within 3 months prior to treatment, unstable arrhythmia, or unstable angina
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Uncontrolled tumor-related pain without stable medication for at least 10 days
- Major surgery, open biopsy, or significant injury within 28 days prior to treatment
- Untreated or actively progressing central nervous system metastases
- Receiving other anti-cancer treatments, except palliative radiation for symptom control while on protocol
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
2
Inova Health Care Service
Falls Church, Virginia, United States, 22042
Not Yet Recruiting
Research Team
E
Elahe Mollapour
CONTACT
K
Keary Jane't
CONTACT
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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