NCT06789757 The Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma (HCC)
| NCT ID | NCT06789757 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Inova Health Care Services |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 19 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2026-10-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 19 participants in total. It began in 2025-02-25 with a primary completion date of 2026-10-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: 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.
Contact & Investigator
Arthur Winer, MD
PRINCIPAL INVESTIGATOR
Principal Investigator
Frequently Asked Questions
Who can join the NCT06789757 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06789757 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06789757 currently recruiting?
Yes, NCT06789757 is actively recruiting participants. Contact the research team at keary.janet@inova.org for enrollment information.
Where is the NCT06789757 trial being conducted?
This trial is being conducted at Fairfax, United States, Falls Church, United States.
Who is sponsoring the NCT06789757 clinical trial?
NCT06789757 is sponsored by Inova Health Care Services. The principal investigator is Arthur Winer, MD at Principal Investigator. The trial plans to enroll 19 participants.
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