Hepatocellular CarcinomaPhase 2/3NCT06007846
A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
A Phase 2/3 study testing Namenda in people with Hepatocellular Carcinoma and Cirrhosis, run by Inova Health Care Services at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Cirrhosis
- What is being tested?
- Namenda
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2023to 31 Jul 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- 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.
- Patient's cancer must be deemed locally advanced and unresectable as per the consensus of the Inova Multidisciplinary Cancer Care Conference.
- Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a candidate for aggressive systemic treatment.
- Eastern Cooperative Oncology Group Performance Status of 0-2.
- Patients must have adequate blood counts and organ function.
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- 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 and for the duration of the study. Women of child bearing potential must have a negative serum pregnancy test result within 24 hours prior to initiation of study treatment. They must also agree to use agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study.
- Patients must demonstrate ability to understand and the willingness to sign a written informed consent document.
- Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.
Who cannot join
- Patients with Child-Pugh A cirrhosis.
- Female patients who are pregnant or breast-feeding.
- Concomitant illness or history that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
- Life-threatening intercurrent illness.
- Anticipated poor compliance.
- Subject is enrolled in a separate interventional clinical trial.
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- Active tuberculosis.
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry for at least 10 days prior to study entry.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- Patients undergoing other anti-cancer treatment. Palliative radiation for symptom control will be allowed while on protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Elahe Mollapour
Keary Jane't
- Not yet recruiting
Inova Health Care Service
Falls Church, Virginia, 22042
Elahe Mollapour, 571-472-0615, elahe.mollapour@inova.org
Keary Jane't, 571-472-3173, keary.janet@inova.org
About this study
Official title: A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma
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
- Hepatocellular Carcinoma, Cirrhosis
- Being tested
- Namenda
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NamendaDrug
Also called Memantine
Memantine 5 mg by mouth once daily, to be titrated up to 20 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Namenda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Progression Free Survival at 6 months
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.
Measured: 6 months from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start31 Jul 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur Winer, MD, Principal investigator, Inova Health Care Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007846
- Sponsor's protocol ID
- U23-01-4957
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabrera R, Nelson DR. Review article: the management of hepatocellular carcinoma. Aliment Pharmacol Ther. 2010 Feb 15;31(4):461-76. doi: 10.1111/j.1365-2036.2009.04200.x. Epub 2009 Nov 19.
PubMed 19925500Rawla P, Sunkara T, Muralidharan P, Raj JP. Update in global trends and aetiology of hepatocellular carcinoma. Contemp Oncol (Pozn). 2018;22(3):141-150. doi: 10.5114/wo.2018.78941. Epub 2018 Sep 30.
PubMed 30455585El-Serag HB, Kanwal F. Epidemiology of hepatocellular carcinoma in the United States: where are we? Where do we go? Hepatology. 2014 Nov;60(5):1767-75. doi: 10.1002/hep.27222. Epub 2014 Aug 25. No abstract available.
PubMed 24839253El-Serag HB, Davila JA, Petersen NJ, McGlynn KA. The continuing increase in the incidence of hepatocellular carcinoma in the United States: an update. Ann Intern Med. 2003 Nov 18;139(10):817-23. doi: 10.7326/0003-4819-139-10-200311180-00009.
PubMed 14623619Liu P, Xie SH, Hu S, Cheng X, Gao T, Zhang C, Song Z. Age-specific sex difference in the incidence of hepatocellular carcinoma in the United States. Oncotarget. 2017 Jul 12;8(40):68131-68137. doi: 10.18632/oncotarget.19245. eCollection 2017 Sep 15.
PubMed 28978103Kim E, Viatour P. Hepatocellular carcinoma: old friends and new tricks. Exp Mol Med. 2020 Dec;52(12):1898-1907. doi: 10.1038/s12276-020-00527-1. Epub 2020 Dec 2.
PubMed 33268834Amit S, Jorge A M. Screening for hepatocellular carcinoma. Gastroenterol Hepatol (N Y). 2008 Mar;4(3):201-8.
PubMed 21904498Singal AG, Lampertico P, Nahon P. Epidemiology and surveillance for hepatocellular carcinoma: New trends. J Hepatol. 2020 Feb;72(2):250-261. doi: 10.1016/j.jhep.2019.08.025.
PubMed 31954490Colagrande S, Inghilesi AL, Aburas S, Taliani GG, Nardi C, Marra F. Challenges of advanced hepatocellular carcinoma. World J Gastroenterol. 2016 Sep 14;22(34):7645-59. doi: 10.3748/wjg.v22.i34.7645.
PubMed 27678348Pons F, Varela M, Llovet JM. Staging systems in hepatocellular carcinoma. HPB (Oxford). 2005;7(1):35-41. doi: 10.1080/13651820410024058.
PubMed 18333159Stuart KE, Anand AJ, Jenkins RL. Hepatocellular carcinoma in the United States. Prognostic features, treatment outcome, and survival. Cancer. 1996 Jun 1;77(11):2217-22. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-M.
PubMed 8635087Sanduzzi-Zamparelli M, Forner A. Systemic doxorubicin and hepatocellular carcinoma: the end of an era never risen up. Lancet Gastroenterol Hepatol. 2019 Jun;4(6):418-420. doi: 10.1016/S2468-1253(19)30091-3. Epub 2019 Apr 4. No abstract available.
PubMed 30954566Kitao A, Matsui O, Yoneda N, Kozaka K, Kobayashi S, Koda W, Gabata T, Yamashita T, Kaneko S, Nakanuma Y, Kita R, Arii S. Hypervascular hepatocellular carcinoma: correlation between biologic features and signal intensity on gadoxetic acid-enhanced MR images. Radiology. 2012 Dec;265(3):780-9. doi: 10.1148/radiol.12120226.
PubMed 23175543Morse MA, Sun W, Kim R, He AR, Abada PB, Mynderse M, Finn RS. The Role of Angiogenesis in Hepatocellular Carcinoma. Clin Cancer Res. 2019 Feb 1;25(3):912-920. doi: 10.1158/1078-0432.CCR-18-1254. Epub 2018 Oct 1.
PubMed 30274981Miura H, Miyazaki T, Kuroda M, Oka T, Machinami R, Kodama T, Shibuya M, Makuuchi M, Yazaki Y, Ohnishi S. Increased expression of vascular endothelial growth factor in human hepatocellular carcinoma. J Hepatol. 1997 Nov;27(5):854-61. doi: 10.1016/s0168-8278(97)80323-6.
PubMed 9382973
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06007846
- Acronym / sponsor ID
- U23-01-4957
- Conditions
- Hepatocellular Carcinoma, Cirrhosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Namenda |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older.
- 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.
- Patient's cancer must be deemed locally advanced and unresectable as per the consensus of the Inova Multidisciplinary Cancer Care Conference.
- Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a candidate for aggressive systemic treatment.
- Eastern Cooperative Oncology Group Performance Status of 0-2.
Key exclusion criteria (13 listed)
- Patients with Child-Pugh A cirrhosis.
- Female patients who are pregnant or breast-feeding.
- Concomitant illness or history that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
- Life-threatening intercurrent illness.
- Anticipated poor compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NamendaAlso: MemantineMemantine 5 mg by mouth once daily, to be titrated up to 20 mg daily | Drug | Arm 1 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 19925500Cabrera R, Nelson DR. Review article: the management of hepatocellular carcinoma. Aliment Pharmacol Ther. 2010 Feb 15;31(4):461-76. doi: 10.1111/j.1365-2036.2009.04200.x. Epub 2009 Nov 19.
- Background: PubMed 30455585Rawla P, Sunkara T, Muralidharan P, Raj JP. Update in global trends and aetiology of hepatocellular carcinoma. Contemp Oncol (Pozn). 2018;22(3):141-150. doi: 10.5114/wo.2018.78941. Epub 2018 Sep 30.
- Background: PubMed 24839253El-Serag HB, Kanwal F. Epidemiology of hepatocellular carcinoma in the United States: where are we? Where do we go? Hepatology. 2014 Nov;60(5):1767-75. doi: 10.1002/hep.27222. Epub 2014 Aug 25. No abstract available.
- Background: PubMed 14623619El-Serag HB, Davila JA, Petersen NJ, McGlynn KA. The continuing increase in the incidence of hepatocellular carcinoma in the United States: an update. Ann Intern Med. 2003 Nov 18;139(10):817-23. doi: 10.7326/0003-4819-139-10-200311180-00009.
- Background: PubMed 28978103Liu P, Xie SH, Hu S, Cheng X, Gao T, Zhang C, Song Z. Age-specific sex difference in the incidence of hepatocellular carcinoma in the United States. Oncotarget. 2017 Jul 12;8(40):68131-68137. doi: 10.18632/oncotarget.19245. eCollection 2017 Sep 15.
- Background: PubMed 33268834Kim E, Viatour P. Hepatocellular carcinoma: old friends and new tricks. Exp Mol Med. 2020 Dec;52(12):1898-1907. doi: 10.1038/s12276-020-00527-1. Epub 2020 Dec 2.
- Background: PubMed 21904498Amit S, Jorge A M. Screening for hepatocellular carcinoma. Gastroenterol Hepatol (N Y). 2008 Mar;4(3):201-8.
- Background: PubMed 31954490Singal AG, Lampertico P, Nahon P. Epidemiology and surveillance for hepatocellular carcinoma: New trends. J Hepatol. 2020 Feb;72(2):250-261. doi: 10.1016/j.jhep.2019.08.025.
- Background: PubMed 27678348Colagrande S, Inghilesi AL, Aburas S, Taliani GG, Nardi C, Marra F. Challenges of advanced hepatocellular carcinoma. World J Gastroenterol. 2016 Sep 14;22(34):7645-59. doi: 10.3748/wjg.v22.i34.7645.
- Background: PubMed 18333159Pons F, Varela M, Llovet JM. Staging systems in hepatocellular carcinoma. HPB (Oxford). 2005;7(1):35-41. doi: 10.1080/13651820410024058.
- Background: PubMed 8635087Stuart KE, Anand AJ, Jenkins RL. Hepatocellular carcinoma in the United States. Prognostic features, treatment outcome, and survival. Cancer. 1996 Jun 1;77(11):2217-22. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-M.
- Background: PubMed 30954566Sanduzzi-Zamparelli M, Forner A. Systemic doxorubicin and hepatocellular carcinoma: the end of an era never risen up. Lancet Gastroenterol Hepatol. 2019 Jun;4(6):418-420. doi: 10.1016/S2468-1253(19)30091-3. Epub 2019 Apr 4. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arthur Winer, MD principal investigator
Inova Health Care Service
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Namenda in people with Hepatocellular Carcinoma and Cirrhosis, run by Inova Health Care Services at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elahe Mollapour (571-472-0615, elahe.mollapour@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Progression Free Survival at 6 months (time frame: 6 months from the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06007846, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.