Actively Recruiting
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
Led by Michael Dill · Updated on 2025-08-06
48
Participants Needed
7
Research Sites
137 weeks
Total Duration
On this page
Sponsors
M
Michael Dill
Lead Sponsor
N
National Center for Tumor Diseases, Heidelberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed radiologic or histological diagnosis of hepatocellular carcinoma
- Disease not suitable for surgery, liver transplant, or local therapies
- Eligible for atezolizumab and bevacizumab treatment as standard care
- Measurable tumor according to RECIST 1.1 criteria
- Preserved liver function with Child-Pugh score A or B (maximum 7 points)
- ECOG performance status 0 or 1
You will not qualify if you...
- Use of immunosuppressive medication within 6 months before starting atezolizumab and bevacizumab
- Active or past autoimmune or inflammatory diseases
- Previous treatment with immune therapies including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-VEGF antibodies
- Known HIV infection
- Co-infection with hepatitis B and C viruses; patients with resolved hepatitis C (negative RNA) are allowed
- Presence of varices at risk of bleeding within 12 months prior to study
- Severe nausea, vomiting, chronic gastrointestinal disease, swallowing difficulties, or major bowel surgery affecting drug absorption
- Uncontrolled high blood pressure despite treatment (systolic > 150 mm Hg or diastolic > 90 mm Hg)
- History of kidney diseases such as nephrotic or nephritic syndrome
- Use of systemic antibiotics within 2 weeks before starting atezolizumab and bevacizumab
- Use of probiotic products within 1 week before starting atezolizumab and bevacizumab
- Known fibrolamellar, sarcomatoid, infiltrative, or mixed cholangiocarcinoma/hepatocellular carcinoma
- History of another primary cancer
- Receipt of live vaccines within 30 days before study intervention
- Pregnancy or breastfeeding
- Known allergy to study drugs or their components
- Participation in other interventional or competing clinical trials
- Legal or official institutionalization
- Legal incapacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
2
University Hospital Augsburg
Augsburg, Germany, 86156
Not Yet Recruiting
3
University Hospital Essen
Essen, Germany, 45147
Not Yet Recruiting
4
University Hospital Mannheim
Mannheim, Germany, 68167
Not Yet Recruiting
5
University Hospital Regensburg
Regensburg, Germany, 93053
Not Yet Recruiting
6
University Hospital Tübingen
Tübingen, Germany, 72076
Not Yet Recruiting
7
University Hospital Ulm
Ulm, Germany, 89081
Not Yet Recruiting
Research Team
M
Michael T Dill, PhD
CONTACT
C
Conrad Rauber, MD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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