Combination therapy for hepatocellular carcinoma using atezolizumab, bevacizumab, and memantine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a triplet therapy combining atezolizumab, bevacizumab, and memantine in patients with hepatocellular carcinoma (HCC). The approach focuses on targeting the NMDA receptor pathway while patients undergo systemic therapy. Participants will receive treatment in 21-day cycles over a period of six months, during which their quality of life and cancer-related symptoms will be assessed through surveys. The goal is to evaluate the efficacy and safety of this combination therapy in treating locally advanced and unresectable HCC.

Why it matters

Who can join: the full rules

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.

Where it's running

• Inova Schar Cancer Institute - Fair Oaks
  Fairfax, Virginia, United States Recruiting
• Inova Health Care Service
  Falls Church, Virginia, United States Recruiting

Study contacts

• Principal investigator: Arthur Winer, MD — Principal Investigator
• Study coordinator: Keary Jane't
• Email: keary.janet@inova.org
• Phone: 571-472-4724

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventive endoscopic banding for high-risk esophageal varices in people with hepatocellular carcinoma starting atezolizumab plus bevacizumab

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• Valemetostat with atezolizumab and bevacizumab for advanced hepatocellular carcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.