A Phase2 study to investigate the efficacy and safety of Atezolizumab and bevacizumab with live bacterial product for unresectable HCC

Tateishi Ryosuke0 个研究点目标入组 44 人开始时间: 2023年3月24日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•(1) With unresectable hepatocellular carcinoma (BCLC stage B or C)
•(2) ECOG PS of 0 or 1
•(3) Child-Pugh class A
•(4) Aged 18 years and above at the time of informed consent
•(5) Male or female
•(6) With at least one measurable lesion (based on RECIST 1.1 and mRECIST) by CT or MRI within 60 days prior to registration
•(7) Laboratory tests within 60 days prior to registration as follows
•1.Neutrophil count >= 1,500/microL
•2.Platelet count >= 20,000/microL
•3.AST and ALT <= 5 times upper limit of normal
•4.Total bilirubin <= 3.0 mg/dL
•5.Albumin >= 2.8 mg/dL
•6.Creatinine <= 1.5 times upper limit of normal
•7.Proteinuria <= 2+
•(If proteinuria is 3+ or more) spot urine protein creatinine ratio < 3.5
•(8) Able to attend all scheduled visits
•(9) Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation

•(1) Having received immune checkpoint inhibitor therapy
•(2) With autoimmune disease taking corticosteroids (equivalent to prednisolone of 10 mg or more) or other immunosuppressive therapy
•(3) Unable to stop eating yogurt or taking probiotics
•(4) With chronic diarrhea
•(5) With a history of myocarditis, heart failure (NYHA of 3 or 4), acute coronary syndrome, severe arrhythmia, or severe infection in the last 6 months
•(6) With malignancy except for hepatocellular carcinoma
•(7) Pregnant or possible pregnant
•(8) Lactating female
•(9) With a history of allergy to components of atezolizumab, bevacizumab or butyrate-producing bacteria
•(10) With a history of hemoptysis
•(11) Judged as ineligible by clinical investigators

发起方

Tateishi Ryosuke