An Open Label Phase II Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR) of patients who are treated with the combination of atezolizumab, bevacizumab, and memantine.
研究概览
简要总结
The purpose of this research is to see the effect of triplet therapy with atezolizumab, bevacizumab, and memantine in treatment of your hepatocellular carcinoma.
详细描述
The goal of this study is to investigate the impact of targeting the NMDA receptor pathway, by enrolling patients with hepatocellular carcinoma undergoing systemic therapy. The study will involve adding memantine to the standard treatment of atezolizumab and bevacizumab, administered in 21-day cycles over six months. Patients will complete quality of life surveys at each cycle to assess their well-being and cancer-related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 A
- •Eastern Cooperative Oncology Group Performance Status of 0-
- •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
- •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.
- •Patients must demonstrate the ability to understand and the willingness to sign a written informed consent document.
- •Men and women, regardless of race, ethnic group, or sexual orientation are eligible for this study.
- •Patient must be able to swallow oral medication.
排除标准
- •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.
- •Subject is enrolled in a separate interventional clinical trial.
- •Active tuberculosis.
- •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.
- •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
- •Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation.
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- •Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry.
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment.
- •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.
研究组 & 干预措施
Addition of Memantine to Atezolizumab and Bevacizumab (the current systemic standard of care)
The study intervention consists of the use of the triplet therapy (atezolizumab, bevacizumab, and memantine) given in 21-day cycles over six months.
干预措施: Memantine Hydrochloride (Drug)
Addition of Memantine to Atezolizumab and Bevacizumab (the current systemic standard of care)
The study intervention consists of the use of the triplet therapy (atezolizumab, bevacizumab, and memantine) given in 21-day cycles over six months.
干预措施: Bevacizumab (Drug)
Addition of Memantine to Atezolizumab and Bevacizumab (the current systemic standard of care)
The study intervention consists of the use of the triplet therapy (atezolizumab, bevacizumab, and memantine) given in 21-day cycles over six months.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Objective response rate (ORR) of patients who are treated with the combination of atezolizumab, bevacizumab, and memantine.
时间窗: Up to 2 years
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.
次要结局
未报告次要终点