Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)

Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA) (NCT05690048) is a Phase 2 interventional studying Immunotherapy and HCC - Hepatocellular Carcinoma, sponsored by Michael Dill. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The interventional, randomized, placebo-controlled, double-blind phase II-trial FLORA will assess safety and immunogenicity of fecal microbiota transfer in combination with standard of care immunotherapy in advanced hepatocellular carcinoma (HCC) in a parallel group design. Subjects will be randomized 2:1 into either the FMT or placebo group.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Immunotherapy and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18 years or older 2. Confirmed radiologic or histological diagnosis of HCC 3. Disease not amenable to resection, liver transplantation or loco-regionary therapy 4. Eligible for therapy with Atezolizumab / Bevacizumab according to standard of care 5. tumors that can be measured on scans 1.1 6. Preserved liver function with a Child-Pugh score A or B (maximally 7 points) 7. Performance status ECOG 0-1 Who Should NOT Join This Trial: 1. Use of immunosuppressive medication within 6 months prior to the first dose of Atezolizumab / Bevacizumab. 2. Active or prior documented autoimmune or inflammatory disorders 3. Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-VEGF antibodies. 4. Known to have tested positive for human weakened immune system virus (HIV) infection. 5. Co-infection of HBV and HCV. Subjects with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV. 6. Evidence by investigator assessment of varices at risk of bleeding on upper endoscopy undertaken within 12 months of randomization. 7. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow a formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism or excretion of investigational product. 8. Uncontrolled arterial hypertension defined by a systolic pressure \> 150 mm Hg or diastolic pressure \> 90 mm Hg or other hypertensive cardiovascular complications despite standard medical treatment. 9. Any history of nephrotic or nephritic syndrome. 10. Usage of systemic antibiotic therapy within 2 weeks prior to the first dose of Atezolizumab/Bevacizumab. 11. Usage of probiotic products/supplements within 1 week prior to the first dose of Atezolizumab/Bevacizumab. 12. Known fibrolamellar HCC, sarcomatoid HCC, infiltrative-type HCC, or mixed cholangiocarcinoma and HCC. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age 18 years or older 2. Confirmed radiologic or histological diagnosis of HCC 3. Disease not amenable to resection, liver transplantation or loco-regionary therapy 4. Eligible for therapy with Atezolizumab / Bevacizumab according to standard of care 5. Measurable disease per RECIST 1.1 6. Preserved liver function with a Child-Pugh score A or B (maximally 7 points) 7. Performance status ECOG 0-1 Exclusion Criteria: 1. Use of immunosuppressive medication within 6 months prior to the first dose of Atezolizumab / Bevacizumab. 2. Active or prior documented autoimmune or inflammatory disorders 3. Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-VEGF antibodies. 4. Known to have tested positive for human immunodeficiency virus (HIV) infection. 5. Co-infection of HBV and HCV. Subjects with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV. 6. Evidence by investigator assessment of varices at risk of bleeding on upper endoscopy undertaken within 12 months of randomization. 7. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow a formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism or excretion of investigational product. 8. Uncontrolled arterial hypertension defined by a systolic pressure \> 150 mm Hg or diastolic pressure \> 90 mm Hg or other hypertensive cardiovascular complications despite standard medical treatment. 9. Any history of nephrotic or nephritic syndrome. 10. Usage of systemic antibiotic therapy within 2 weeks prior to the first dose of Atezolizumab/Bevacizumab. 11. Usage of probiotic products/supplements within 1 week prior to the first dose of Atezolizumab/Bevacizumab. 12. Known fibrolamellar HCC, sarcomatoid HCC, infiltrative-type HCC, or mixed cholangiocarcinoma and HCC. 13. History of another primary malignancy. 14. Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. 15. Pregnancy or lactation. 16. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. 17. Participation in other interventional clinical trials or observation period of competing clinical trials, respectively. 18. Held in an institution by legal or official order. 19. Legally incapacitated. 20. Known hypersensitivity to any component of the vancomycin, atezolizumab or bevacizumab formulation.

Treatments Being Tested

DRUG

Fecal microbiota transfer

FMT via capsule (50 g of fecal matter) on day 0 and day 21.

DRUG

Vancomycin Oral Capsule

Vancomycin orally (250 mg 4xd, day -3 to 0).

DRUG

Atezolizumab + Bevacizumab

Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).

DRUG

Placebo Vancomycin Oral Capsule

Placebo Vancomycin orally (4xd, day -3 to 0).

DRUG

Placebo Fecal microbiota transfer

Placebo Fecal microbiota transfer (FMT) via capsule on day 0 and day 21.

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

University Hospital Augsburg

Augsburg, Germany

University Hospital Essen

Essen, Germany

University Hospital Mannheim

Mannheim, Germany

University Hospital Regensburg

Regensburg, Germany

University Hospital Tübingen

Tübingen, Germany

University Hospital Ulm

Ulm, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05690048), the sponsor (Michael Dill), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05690048 clinical trial studying?

Who can participate in NCT05690048?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05690048?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05690048. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05690048. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.