NCT05690048 Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
| NCT ID | NCT05690048 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Michael Dill |
| Condition | Immunotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2025-07-16 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Michael T Dill, PhD
PRINCIPAL INVESTIGATOR
University Hospital Heidelberg, Heidelberg, Baden-Württemberg 69120
Frequently Asked Questions
Who can join the NCT05690048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immunotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05690048 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05690048 currently recruiting?
Yes, NCT05690048 is actively recruiting participants. Contact the research team at michael.dill@med.uni-heidelberg.de for enrollment information.
Where is the NCT05690048 trial being conducted?
This trial is being conducted at Heidelberg, Germany, Augsburg, Germany, Essen, Germany, Mannheim, Germany and 3 additional locations.
Who is sponsoring the NCT05690048 clinical trial?
NCT05690048 is sponsored by Michael Dill. The principal investigator is Michael T Dill, PhD at University Hospital Heidelberg, Heidelberg, Baden-Württemberg 69120. The trial plans to enroll 48 participants.