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

JRCT ID: jRCTs031220724

Registered date:24/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 25/08/2023
• Target sample size: 44
• Study type: Interventional
• Intervention(s): Butyrate-producing bacteria as add-on therapy to atezolizumab and bevacizumab combination therapy for unresectable hepatocellular carcinoma

Outcome(s)

• Primary Outcome: Overall response rate (RECIST ver1.1)

Secondary Outcome

(1) Overall response rate (mRECIST)
(2) Progression Free Survival (RECIST ver1.1 and mRECIST)
(3) Progression free survival rate at 12 months (RECIST ver1.1 and mRECIST)
(4) Overall survival
(5) Overall survival rate at 12 months
(6) Incidence and rate of adverse events related to the treatment (diarrhea and constipation)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Tateishi Ryosuke