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FMT in IT-refractory HCC - FAB-HCC Pilot Study
EU CTIS ID: 2024-516835-29-00
What this study is testing
Safety as measured by incidence and severity of treatment-related adverse events, with severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent form
- 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
- Age ≥ 18 years
- Histologically or radiologically confirmed HCC
You likely can't join if
- Known fibrolamellar carcinoma or mixed cholangiocellular carcinoma
- Pregnant or breastfeeding women
- Treatment 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 insufficiency
- 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
See the full eligibility criteria
Who can join
- Signed informed consent form
- 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
- 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
What rules you out
- Known fibrolamellar carcinoma or mixed cholangiocellular carcinoma
- Pregnant or breastfeeding women
- Treatment 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 insufficiency
- 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
- Serious, non-healing wound or active ulcer
- Massive tumor progression (>100% increase in target lesions or progression associated with significant clinical deterioration)
- Uncontrolled ascites
- Overt hepatic encephalopathy or concomitant treatment with rifaximin
- Prior allogeneic stem cell or solid organ transplantation
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.