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

This single-center, pilot study (phase IIa) will evaluate the safety, feasibility, and efficacy of FMT from patients with HCC who responded to PD-(L)1-based immunotherapy to patients with HCC who failed to respond to atezolizumab/bevacizumab.

Inclusion Criteria:Signed informed consent formAge ≥ 18 yearsHistologically or radiologically confirmed HCCPatients with progressive disease (according to mRECIST) during treatment with atezolizumab/bevacizumab (without 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 treatmentNegative HIV testPatients with chronic hepatitis B must be under antiviral treatment and hepatitis B DNA must be < 500 IU/mLVariceal status must be known and if present, adequate medical or endoscopic treatment is requiredECOG Performance Status 0-1Child-Pugh class A-B8Adequate hematological and end-organ function, defined as follows:AST and ALT < 10 x ULNSerum bilirubin < 3.5 mg/dLAlbumin ≥ 28 g/LSerum creatinine ≤ 1.5 mg/dLHemoglobin ≥ 8 mg/dLPlatelet count ≥ 50 G/LLeukocytes ≥ 2.5 G/LPatients 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 methodsMen must agree to remain abstinent (refrain from heterosexual intercourse) or use a condomExclusion Criteria:Known fibrolamellar carcinoma or mixed cholangiocellular carcinomaMassive tumor progression (> 100% increase in target lesions or progression associated with significant clinical deterioration)Uncontrolled ascitesOvert hepatic encephalopathy or concomitant treatment with rifaximinPrior allogeneic stem cell or solid organ transplantationActive or history of severe autoimmune diseaseHistory of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitisSignificant 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 anginaSevere infection within 4 weeks prior to study inclusionPregnant or breastfeeding womenTreatment with systemic immunosuppressive medication with the following exceptions: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 insufficiencySignificant vascular disease (e.g., peripheral arterial thrombosis) within 6 months prior to study inclusionMajor surgery within 4 weeks prior to study inclusion or minor surgery (excluding placement of a vascular access device) within 3 days prior to study inclusionHistory of gastrointestinal fistula or perforation, or intraabdominal abscess within 6 months prior to study inclusionSerious, non-healing wound or active ulcer