Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID06007846

A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma

Led by Inova Health Care Services · Updated on 2025-09-30

12

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

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 drug's 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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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

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Research Team

E

Elahe Mollapour

K

Keary Jane't

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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