Stool transplantation combined with atezolizumab plus bevacizumab in patients with liver cancer who failed to respond to prior immunotherapy – the FAB-HCC Trial

Fecal Microbiota Transplant (FMT) combined with Atezolizumab plus Bevacizumab in Patients with HepatoCellular Carcinoma who failed to respond to prior Immunotherapy – the FAB-HCC Trial - FMT in IT-refractory HCC – FAB-HCC Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000234-42-AT

Enrollment

Registered

2022-02-07

Start date

2022-05-27

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma MedDRA version: 21.1 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 100000004864

Interventions

Trade Name: Tecentriq 1200mg Product Name: Atezolizumab Product Code: RO5541267 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Atezolizumab CAS Number: 1380723-44-3 Cu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Signed informed consent form ? Age 18 years or older ? 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: ? Known fibrolamellar carcinoma or mixed cholangiocellular carcinoma ? 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety and feasibility of FMT from patients with HCC who responded to PD-(L)1-based immunotherapy to patients with HCC who failed to achieve or maintain a response to atezolizumab/bevacizumab in combination with atezolizumab/bevacizumab;Secondary Objective: Efficacy of FMT from patients with HCC who responded to PD-(L)1-based immunotherapy to patients with HCC who failed to achieve or maintain a response to atezolizumab/bevacizumab in combination with atezolizumab/bevacizumab;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: At every visit	—

Measure

Time frame

Main Objective: Safety and feasibility of FMT from patients with HCC who responded to PD-(L)1-based immunotherapy to patients with HCC who failed to achieve or maintain a response to atezolizumab/bevacizumab in combination with atezolizumab/bevacizumab;Secondary Objective: Efficacy of FMT from patients with HCC who responded to PD-(L)1-based immunotherapy to patients with HCC who failed to achieve or maintain a response to atezolizumab/bevacizumab in combination with atezolizumab/bevacizumab;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: At every visit

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Secondary

Measure	Time frame
Secondary end point(s): • Efficacy as assessed by best radiological response according to mRECIST and RECIST v1.1 criteria • Efficacy as assessed by objective response rate and disease control rate • Efficacy as assessed by progression-free survival and overall survival • Quality of life as assessed EQ-5D-5L questionnaire ;Timepoint(s) of evaluation of this end point: Continuously at the time points specified in protocol	—

Measure

Time frame

Secondary end point(s): • Efficacy as assessed by best radiological response according to mRECIST and RECIST v1.1 criteria • Efficacy as assessed by objective response rate and disease control rate • Efficacy as assessed by progression-free survival and overall survival • Quality of life as assessed EQ-5D-5L questionnaire ;Timepoint(s) of evaluation of this end point: Continuously at the time points specified in protocol

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Countries

Austria

Contacts

Public ContactMatthias Pinter

Medical University of Vienna

matthias.pinter@meduniwien.ac.at+4314040065890

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026