Actively Recruiting

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

A Prospective Study of Memantine in Patients With Liver Cirrhosis and Advanced Hepatocellular Carcinoma Evaluating Memantine for Patients Not Eligible for Intensive Therapy

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

Researchers are evaluating the effects of memantine in patients with hepatocellular carcinoma (HCC) who also have cirrhosis with a Child-Pugh score of B7 or higher. These patients have locally advanced, unresectable cancer and are not suitable for intensive systemic therapy. This prospective study aims to assess the drug's efficacy, focusing on progression-free survival at 6 months, along with multiple secondary efficacy endpoints and quality of life changes over time. Participants will receive memantine starting at 5 mg daily by mouth, with doses gradually increased up to 20 mg daily. The study is conducted at a single site and involves patients with newly diagnosed, untreated HCC confirmed by histology or imaging. Prior treated lesions are allowed if treated over 2 years ago. The treatment period and dosing adjustments will be closely monitored. Throughout the study, patients will be regularly assessed for cancer progression and overall health. Researchers will collect data on progression-free survival at 6 months from treatment start, monitor quality of life, and evaluate safety. Participants must meet specific health and organ function requirements and will be asked to provide informed consent. Safety measures include pregnancy testing and contraception use for those of childbearing potential. The study excludes patients with certain conditions or treatments that might interfere with assessments or increase risk.

CONDITIONS

Official 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, 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
Not Eligible

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

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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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