NCT06007846 A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer
| NCT ID | NCT06007846 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Inova Health Care Services |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-07-31 |
| Primary Completion | 2028-07-31 |
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 12 participants in total. It began in 2023-07-31 with a primary completion date of 2028-07-31.
⚠ 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
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.
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 as per the consensus of the Inova Multidisciplinary Cancer Care Conference. 4. Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a candidate for aggressive systemic treatment. 5. Eastern Cooperative Oncology Group Performance Status of 0-2. 6. Patients must have adequate blood counts and organ function. 7. 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. 8. Patients must demonstrate 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. Exclusion Criteria: 1. Patients with Child-Pugh A cirrhosis. 2. Female patients who are pregnant or breast-feeding. 3. Concomitant illness or history that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants. 4. Life-threatening intercurrent illness. 5. Anticipated poor compliance. 6. Subject is enrolled in a separate interventional clinical trial. 7. Active tuberculosis. 8. 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. 9. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 10. 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. 11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment. 12. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. 13. Patients undergoing other anti-cancer treatment. Palliative radiation for symptom control will be allowed while on protocol.
Contact & Investigator
Arthur Winer, MD
PRINCIPAL INVESTIGATOR
Inova Health Care Service
Frequently Asked Questions
Who can join the NCT06007846 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 NCT06007846 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 NCT06007846 currently recruiting?
Yes, NCT06007846 is actively recruiting participants. Contact the research team at elahe.mollapour@inova.org for enrollment information.
Where is the NCT06007846 trial being conducted?
This trial is being conducted at Fairfax, United States, Falls Church, United States.
Who is sponsoring the NCT06007846 clinical trial?
NCT06007846 is sponsored by Inova Health Care Services. The principal investigator is Arthur Winer, MD at Inova Health Care Service. The trial plans to enroll 12 participants.
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