FMT in IT-refractory HCC - FAB-HCC Pilot Study

Prior treatment

• Overt hepatic encephalopathy or concomitant treatment with rifaximin
• Prior allogeneic stem cell or solid organ transplantation
• 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 study inclusion or unstable angina
• Severe infection within 4 weeks prior to study inclusion
• Treatment with systemic immunosuppressive medication with the following exceptions:
• Significant vascular disease (e.g., peripheral arterial thrombosis) within 6 months prior to study inclusion
• Major surgery within 4 weeks prior to study inclusion or minor surgery (excluding placement of a vascular access device) within 3 days prior to study inclusion
• History of gastrointestinal fistula or perforation, or intraabdominal abscess within 6 months prior to study inclusion

Other illness

• Active or history of severe autoimmune disease
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
• Acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for contrast allergy)
• Mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for adrenal insufficiency
• Serious, non-healing wound or active ulcer

Other

• Known fibrolamellar carcinoma or mixed cholangiocellular carcinoma
• Massive tumor progression (\> 100% increase in target lesions or progression associated with significant clinical deterioration)
• Uncontrolled ascites
• Pregnant or breastfeeding women

• Signed informed consent form
• Age ≥ 18 years
• Histologically or radiologically confirmed HCC
• Patients with progressive disease (according to mRECIST) during treatment with atezolizumab/bevacizumab (without or with prior complete or partial response as best radiological response according to mRECIST) OR patients with stable disease as best radiological response (according to mRECIST) after the first 12 months of atezolizumab/bevacizumab treatment
• Negative HIV test
• Patients with chronic hepatitis B must be under antiviral treatment and hepatitis B DNA must be \< 500 IU/mL
• Variceal status must be known and if present, adequate medical or endoscopic treatment is required
• ECOG Performance Status 0-1
• Child-Pugh class A-B8
• Adequate hematological and end-organ function, defined as follows:
• AST and ALT \< 10 x ULN
• Serum bilirubin \< 3.5 mg/dL
• Albumin ≥ 28 g/L
• Serum creatinine ≤ 1.5 mg/dL
• Hemoglobin ≥ 8 mg/dL
• Platelet count ≥ 50 G/L
• Leukocytes ≥ 2.5 G/L
• Patients not receiving therapeutic anticoagulation: INR ≤ 2.3 or thromboplastin time ≥ 40%
• Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
• Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom