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Hepatocellular CarcinomaPhase 2(HCC)NCT06789757

The Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma (HCC)

A Phase 2 study testing Memantine Hydrochloride, Bevacizumab and Atezolizumab in people with Hepatocellular Carcinoma, run by Inova Health Care Services at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this research is to see the effect of triplet therapy with atezolizumab, bevacizumab, and memantine in treatment of your hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Memantine Hydrochloride, Bevacizumab and Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
2 sitesUnited States
Study dates
25 Feb 2025to 27 Jan 2030
Phase
Phase 2
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
  • Patients must have a Childs-Pugh cirrhosis score of A5 or A6.
  • Eastern Cooperative Oncology Group Performance Status of 0-1.
  • Patients must have bone marrow and organ function as defined below:
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  • Absolute Neutrophil Count ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Hemoglobin ≥ 90 g/L (9g/dL)
  • Total Bilirubin ≤ 3 x ULN
  • AST(SGOT)/ALT(SGPT)/Alkaline Phosphatase ≤ 3 x ULN Or ≤5x ULN if due to liver involvement by tumor
  • Creatinine ≤ 2.0 mg/dL
  • eGFR (using Cockcroft Gault equation) > 40ml/min
  • Chemotherapy is harmful to the human fetus. For this reason, sexually active males and females 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.
  • Patients must demonstrate the 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.
  • Patient must be able to swallow oral medication.

Who cannot join

  • Patients with Childs-Pugh B or C cirrhosis.
  • Female patients who are pregnant or breast-feeding.
  • Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
  • Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study. This would include any uncontrolled or untreated viral infection such as HIV, HBV, HCV etc.
  • Subject is enrolled in a separate interventional clinical trial.
  • Active tuberculosis.
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  • 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.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation.
  • 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.
  • 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.
  • 18. Active, untreated grade 2 or 3 varices. Patients with treated varices to the point that they are grade 1 or less will be allowed.
  • 19. Patients already on memantine for any reason prior to enrollment will be excluded.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Keary Jane't contact

571-472-4724

keary.janet@inova.org

Elahe Mollapour contact

571-472-4724

elahe.mollapour@inova.org

United States2 sites, 2 recruiting

  • Inova Schar Cancer Institute - Fair Oaks

    Fairfax, Virginia, 22033

    Keary Jane't, 571-472-3173, keary.janet@inova.org

    Arthur Winer, MD

    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

    Recruiting

Other trials in United States

About this study

Official title: An Open Label Phase II Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma

The purpose of this research is to see the effect of triplet therapy with atezolizumab, bevacizumab, and memantine in treatment of your hepatocellular carcinoma.

Read the detailed description

The goal of this study is to investigate the impact of targeting the NMDA receptor pathway, by enrolling patients with hepatocellular carcinoma undergoing systemic therapy. The study will involve adding memantine to the standard treatment of atezolizumab and bevacizumab, administered in 21-day cycles over six months. Patients will complete quality of life surveys at each cycle to assess their well-being and cancer-related symptoms.

Being tested
Memantine Hydrochloride, Bevacizumab, Atezolizumab
Keywords
Atezolizumab, Bevacizumab, Memantine
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Memantine HydrochlorideDrug

    Also called Namenda

    Memantine (5mg) is an N-methyl-D-aspartate (NMDA) receptor antagonist given in 21-day cycles over six months in combination with Bevacizumab and Atezolizumab. Each week memantine will be escalated by 5mg as tolerated

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab (15mg/kg) is a vascular endothelial growth factor inhibitor given in 21-day cycles over six months in combination with Memantine and Atezolizumab.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab (1200mg) is a programmed death-ligand 1 (PD-L1) blocking antibody given in 21-day cycles over six months in combination with Memantine and Bevacizumab

Study groups in NCT06789757
Study groupRoleWhat they receive
Addition of Memantine to Atezolizumab and Bevacizumab (the current systemic standard of care)ExperimentalThe study intervention consists of the use of the triplet therapy (atezolizumab, bevacizumab, and memantine) given in 21-day cycles over six months.
Receives: Drug: Memantine Hydrochloride; Drug: Bevacizumab; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) of patients who are treated with the combination of atezolizumab, bevacizumab, and memantine.

    The effectiveness of the combination therapy using Azozolizumab, Bevacizumab,and Memantine in relation to the Objective Response Rate (ORR), defined as the proportion of complete or partial responses to the treatment by the response evaluation criteria for solid tumors(RECIST) 1.1.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2025
  2. Study start25 Feb 2025
  3. Primary completion27 Oct 2028 (estimated)
  4. Study completion27 Jan 2030 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06789757
Sponsor's protocol ID
INOVA-2023-74
Acronym
(HCC)
Status last verified
Oct 2026
First submitted
13 Nov 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
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 19925500

  • Rawla 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 30455585

  • El-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 24839253

  • Liu 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 28978103

  • Kim 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 33268834

  • Amit S, Jorge A M. Screening for hepatocellular carcinoma. Gastroenterol Hepatol (N Y). 2008 Mar;4(3):201-8.

    PubMed 21904498

  • Singal 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 31954490

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Memantine Hydrochloride, Bevacizumab and Atezolizumab in people with Hepatocellular Carcinoma, 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 17 inclusion and 15 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 16 Oct 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 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.

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 Keary Jane't (571-472-4724, keary.janet@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) of patients who are treated with the combination of atezolizumab, bevacizumab, and memantine. (time frame: Up to 2 years). 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 NCT06789757, which also lists 7 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 16 Oct 2026.

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