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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInova Health Care Services

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Memantine Hydrochloride

    Drug

    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

  • Bevacizumab

    Drug

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

  • Atezolizumab

    Drug

    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

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: Addition of Memantine to Atezolizumab and Bevacizumab (the current systemic standard of care)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
Up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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