RecruitingPhase 2NCT05690048

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


Sponsor

Michael Dill

Enrollment

48 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (FLORA) tests whether a fecal microbiota transplant (FMT) — transferring gut bacteria from a healthy donor — can help people with advanced liver cancer (hepatocellular carcinoma, or HCC) respond better to a standard immunotherapy combination (atezolizumab and bevacizumab). **You may be eligible if...** - You are 18 or older - You have confirmed liver cancer (HCC) that cannot be surgically removed, transplanted, or treated locally - You are eligible for the standard immunotherapy combination (atezolizumab and bevacizumab) - Your liver function is preserved (Child-Pugh A or early B) - You have measurable disease on scans - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have taken immunosuppressive drugs in the past 6 months - You have an active autoimmune or inflammatory condition - You have previously received immune checkpoint therapy (like anti-PD-1 or anti-CTLA-4) - You are HIV positive - You have both hepatitis B and hepatitis C infections - You have uncontrolled high blood pressure or varicose veins in the esophagus at risk of bleeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFecal microbiota transfer

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

DRUGVancomycin Oral Capsule

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

DRUGAtezolizumab + Bevacizumab

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

DRUGPlacebo Vancomycin Oral Capsule

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

DRUGPlacebo Fecal microbiota transfer

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


Locations(7)

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

View Full Details on ClinicalTrials.gov

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NCT05690048


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