RECRUITING

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

Conditions

Hepatocellular Carcinoma Atezolizumab Bevacizumab Memantine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02-25

Study Completion:2027-01-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06789757

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 or older. 2. 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. 3. Patient's cancer must be deemed locally advanced and unresectable 4. Patients must have a Childs-Pugh cirrhosis score of A5 or A6. 5. Eastern Cooperative Oncology Group Performance Status of 0-1. 6. Patients must have bone marrow and organ function as defined below: * 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 7. 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. 8. Patients must demonstrate the ability to understand and the willingness to sign a written informed consent document. 9. Men and women, regardless of race, ethnic group, or sexual orientation are eligible for this study. 10. Patient must be able to swallow oral medication.	1. Patients with Childs-Pugh B or C cirrhosis. 2. Female patients who are pregnant or breast-feeding. 3. Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants. 4. 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. 5. Subject is enrolled in a separate interventional clinical trial. 6. Active tuberculosis. 7. 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. 8. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. 9. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation. 10. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 11. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry. 12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment. 13. 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.

Inclusion Criteria

Exclusion Criteria

1. Age 18 or older.
2. 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.
3. Patient's cancer must be deemed locally advanced and unresectable
4. Patients must have a Childs-Pugh cirrhosis score of A5 or A6.
5. Eastern Cooperative Oncology Group Performance Status of 0-1.
6. Patients must have bone marrow and organ function as defined below:
* 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
7. 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.
8. Patients must demonstrate the ability to understand and the willingness to sign a written informed consent document.
9. Men and women, regardless of race, ethnic group, or sexual orientation are eligible for this study.
10. Patient must be able to swallow oral medication.

1. Patients with Childs-Pugh B or C cirrhosis.
2. Female patients who are pregnant or breast-feeding.
3. Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
4. 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.
5. Subject is enrolled in a separate interventional clinical trial.
6. Active tuberculosis.
7. 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.
8. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
9. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation.
10. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
11. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry.
12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment.
13. 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.

Contacts and Locations

Study Contact

Keary Jane't

CONTACT

571-472-4724

keary.janet@inova.org

Elahe Mollapour

CONTACT

571-472-4724

elahe.mollapour@inova.org

Principal Investigator

Arthur Winer, MD

PRINCIPAL_INVESTIGATOR

Principal Investigator

Study Locations (Sites)

Inova Health Care Service

Falls Church, Virginia, 22042

United States

Collaborators and Investigators

Sponsor: Inova Health Care Services

Arthur Winer, MD, PRINCIPAL_INVESTIGATOR, Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-25

Study Completion Date2027-01-27

Study Record Updates

Study Start Date2025-02-25

Study Completion Date2027-01-27

Terms related to this study

Keywords Provided by Researchers

Atezolizumab
Bevacizumab
Memantine

Additional Relevant MeSH Terms

Hepatocellular Carcinoma