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AzTrials

Hepatocellular CarcinomaPhase 2NCT05750030

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

A Phase 2 study testing FMT combined with Atezolizumab plus Bevacizumab in people with Hepatocellular Carcinoma, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
FMT combined with Atezolizumab plus Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteAustria
Study dates
16 May 2023to 17 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: Fecal Microbiota Transplant (FMT) Combined With Atezolizumab Plus Bevacizumab in Patients With HepatoCellular Carcinoma Who Failed to Respond to Prior Immunotherapy - the 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.

Read the detailed description

The main purpose of this phase IIa pilot study is to test the safety and efficacy of fecal microbiota transplant (FMT) combined with atezolizumab plus bevacizumab in patients who failed to achieve or maintain a complete or partial radiological response (according to mRECIST) to prior immunotherapy for advanced hepatocellular carcinoma (aHCC).

The primary objective is to assess the safety of FMT combined with atezolizumab plus bevacizumab, as measured by incidence and severity of treatment-related adverse events.

The secondary objectives are to assess the efficacy of FMT in combination with atezolizumab plus bevacizumab as measured by best radiological response, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Furthermore, the objective is to evaluate the impact of FMT with atezolizumab plus bevacizumab on the quality of life, as assessed by EQ-5D-5L questionnaires.

Finally, this study also aims to assess the following exploratory endpoints:

  • the effect of FMT on recipient gut microbiota composition, diversity, rate of change from baseline, and similarity to donor stool composition over time (compared between responders and non-responders)
  • the effect of FMT on immune activity in the gut
  • metagenome assemblies and functional profiling before and after FMT
  • single cell analyses of circulating immune cells before and after FMT
  • serum and stool metabolomic and lipidomic signatures before and after FMT

This is a phase II, single-center, open-label pilot study. Twelve patients suffering from advanced-stage hepatocellular carcinoma will be enrolled in this trial. The planned duration for this study are 48 months.

Being tested
FMT combined with Atezolizumab plus Bevacizumab
Keywords
Fecal Microbiota Transplant, Hepatocellular Carcinoma, FMT, HCC, Immunotherapy, Atezolizumab, Bevacizumab
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FMT combined with Atezolizumab plus BevacizumabCombination product

    Single FMT from patients with HCC who responded to PD-(L)1-based immunotherapy to patients with HCC who failed to achieve complete or partial response (according to mRECIST) to atezolizumab/bevacizumab. After single FMT, patients will continue to receive atezolizumab/bevacizumab every 21-days according to protocol.

Study groups in NCT05750030
Study groupRoleWhat they receive
FMT combined with Atezolizumab plus BevacizumabExperimentalNot described
Receives: Combination Product: FMT combined with Atezolizumab plus Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of atezolizumab/bevacizumab in combination with FMT, measured by incidence and severity of treatment-related adverse events, determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.

    Measured: 24 months

Secondary outcomes (4)

  1. Efficacy assessed by the number of study participants achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) as best radiological response evaluated according to mRECIST/ RECIST v1.1 criteria.

    Measured: 24 months

  2. Efficacy as assessed by objective response rate (ORR) and disease control rate (DCR). Objective response is defined as either complete or partial response, while disease control rate comprises complete/partial response as well as stable disease.

    Measured: 24 months

  3. Efficacy as assessed by progression-free survival (PFS) and overall survival (OS).

    Measured: 24 months

  4. Quality of life (QoL) as assessed by the patient-reported outcome EQ-5D-5L (European Quality of Life 5 Dimensions 3 Level Version) questionnaire.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2023
  2. Study start16 May 2023
  3. Primary completion17 Mar 2025
  4. Study completion17 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
12 Patients with HCC who failed to achieve or maintain a complete or partial response (according to mRECIST) to atezolizumab plus bevacizumab
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05750030
Sponsor's protocol ID
FAB0001
Other IDs
2022-000234-42
Status last verified
May 2025
First submitted
16 Jan 2023
Last updated
6 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pomej K, Frick A, Scheiner B, Balcar L, Pajancic L, Klotz A, Kreuter A, Lampichler K, Regnat K, Zinober K, Trauner M, Tamandl D, Gasche C, Pinter M. Study protocol: Fecal Microbiota Transplant combined with Atezolizumab/Bevacizumab in Patients with Hepatocellular Carcinoma who failed to achieve or maintain objective response to Atezolizumab/Bevacizumab - the FAB-HCC pilot study. PLoS One. 2025 Apr 15;20(4):e0321189. doi: 10.1371/journal.pone.0321189. eCollection 2025.

    PubMed 40233040

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FMT combined with Atezolizumab plus Bevacizumab in people with Hepatocellular Carcinoma, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of atezolizumab/bevacizumab in combination with FMT, measured by incidence and severity of treatment-related adverse events, determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05750030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.

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