JPRN-jRCTs031220724
Recruiting
Phase 2
A Phase2 study to investigate the efficacy and safety of Atezolizumab and bevacizumab with live bacterial product for unresectable HCC
Tateishi Ryosuke0 sites44 target enrollmentMarch 24, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hepatocellular carcinoma
- Sponsor
- Tateishi Ryosuke
- Enrollment
- 44
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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