ImmunotherapyPhase 2FLORANCT05690048
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
A Phase 2 study testing Fecal microbiota transfer, Vancomycin Oral Capsule and Atezolizumab + Bevacizumab in people with Immunotherapy and HCC - Hepatocellular Carcinoma, run by Michael Dill at 7 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunotherapy, HCC - Hepatocellular Carcinoma
- What is being tested?
- Fecal microbiota transfer, Vancomycin Oral Capsule and Atezolizumab + Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 7 sitesGermany
- Study dates
- 16 Jul 2025to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older
- Confirmed radiologic or histological diagnosis of HCC
- Disease not amenable to resection, liver transplantation or loco-regionary therapy
- Eligible for therapy with Atezolizumab / Bevacizumab according to standard of care
- Measurable disease per RECIST 1.1
- Preserved liver function with a Child-Pugh score A or B (maximally 7 points)
- Performance status ECOG 0-1
Who cannot join
- Use of immunosuppressive medication within 6 months prior to the first dose of Atezolizumab / Bevacizumab.
- Active or prior documented autoimmune or inflammatory disorders
- 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.
- Known to have tested positive for human immunodeficiency virus (HIV) infection.
- 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.
- Evidence by investigator assessment of varices at risk of bleeding on upper endoscopy undertaken within 12 months of randomization.
Show all 20Show fewer
- 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.
- 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.
- Any history of nephrotic or nephritic syndrome.
- Usage of systemic antibiotic therapy within 2 weeks prior to the first dose of Atezolizumab/Bevacizumab.
- Usage of probiotic products/supplements within 1 week prior to the first dose of Atezolizumab/Bevacizumab.
- Known fibrolamellar HCC, sarcomatoid HCC, infiltrative-type HCC, or mixed cholangiocarcinoma and HCC.
- History of another primary malignancy.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.
- Pregnancy or lactation.
- 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.
- Participation in other interventional clinical trials or observation period of competing clinical trials, respectively.
- Held in an institution by legal or official order.
- Legally incapacitated.
- Known hypersensitivity to any component of the vancomycin, atezolizumab or bevacizumab formulation.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Not yet recruiting
University Hospital Augsburg
Augsburg, 86156
Alexander Reichart, Dr.
- Not yet recruiting
University Hospital Essen
Essen, 45147
Leonie Jochheim, Dr.
- Recruiting
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Michael Dill, PhD
Conrad Rauber, PhD
- Not yet recruiting
University Hospital Mannheim
Mannheim, 68167
Andreas Teufel, Prof.
- Not yet recruiting
University Hospital Regensburg
Regensburg, 93053
Arne Kandulski, Prof.
- Not yet recruiting
University Hospital Tübingen
Tübingen, 72076
Pavlos Missios, Dr.
- Not yet recruiting
University Hospital Ulm
Ulm, 89081
Thomas J Ettrich, Dr.
About this study
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.
Read the detailed description
Eligible HCC patients visiting the outpatient clinics at the study sites of the NCT Germany will be enrolled into the study after informed consent. Patients undergo 2:1 randomization into either the FMT or placebo group. Prior to the intervention, a sigmoidoscopy with mucosal biopsies will be performed. At day -3 to 0 oral Vancomycin 4x 250mg or placebo will be given. Atezolizumab/bevacizumab (A/B) will be administered as standard of care every 21 days, starting on day 0. At day 0 and 21, concurrent to the first and second cycle of A/B, encapsulated FMT or placebo will be administered on the same day. At day 40-42, before the third cycle of A/B, a tumor biopsy and a sigmoidoscopy will be performed. The first radiologic assessment will be performed after 4 cycles of A/B. Clinical efficacy and safety will be assessed as indicated per protocol analysis.
- Conditions
- Immunotherapy, HCC - Hepatocellular Carcinoma
- Being tested
- Fecal microbiota transfer, Vancomycin Oral Capsule, Atezolizumab + Bevacizumab, Placebo Vancomycin Oral Capsule, Placebo Fecal microbiota transfer
- Keywords
- immunotherapy, fecal microbiota transfer, HCC, gut microbiota, tumor microenvironment
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transferDrug
Also called FMT, INTESTIFIX 001
FMT via capsule (50 g of fecal matter) on day 0 and day 21.
Vancomycin Oral CapsuleDrug
Vancomycin orally (250 mg 4xd, day -3 to 0).
Atezolizumab + BevacizumabDrug
Also called A/B
Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).
Placebo Vancomycin Oral CapsuleDrug
Placebo Vancomycin orally (4xd, day -3 to 0).
Placebo Fecal microbiota transferDrug
Also called Placebo FMT, Placebo INTESTIFIX 001
Placebo Fecal microbiota transfer (FMT) via capsule on day 0 and day 21.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin + A/B + FMT | Experimental | 1. Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).
2. Vancomycin orally (250 mg 4xd, day -3 to 0) for reduction of original patient gut microbiota.
3. Fecal microbiota transfer (FMT) via capsules (total 50 g of fecal matter) on day 0 and day 21. Receives: Drug: Fecal microbiota transfer; Drug: Vancomycin Oral Capsule; Drug: Atezolizumab + Bevacizumab |
| Placebo Vancomycin + A/B + Placebo FMT | Placebo comparator | 1. Atezolizumab 1200mg i.v. \& bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).
2. Placebo vancomycin orally (4xd, day -3 to 0) for reduction of original patient gut microbiota.
3. Placebo fecal microbiota transfer (FMT) via capsules on day 0 and day 21. Receives: Drug: Atezolizumab + Bevacizumab; Drug: Placebo Vancomycin Oral Capsule; Drug: Placebo Fecal microbiota transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of immunogenicity
Tumoral CD8+ T cell infiltration after 2 cycles of treatment with Vancomycin, A/B + FMT in comparison to Vancomycin-placebo, A/B + FMT-placebo
Measured: 6 weeks after treatment initiation
Safety of the therapeutic combination in advanced HCC
Occurence of Adverse Events (AE) \& immune-related adverse events (irAE)
Measured: The observational period begins with the first administration of the 1st IMP (Vancomycin/Placebo) on day -3 and ends with either the Follow-up visit after 15 weeks (Day 105) or the initiation of a subsequent anticancer treatment.
Secondary outcomes (12)
Overall survival (OS)
To evaluate the efficacy of Vancomycin, A/B + INTESTIFIX 001 in comparison to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to Overall Survival (OS).
OS is defined as the time from start of treatment (first dose of A/B) to time of death from any cause in days. Administrative censoring is applied for patients who survive the end of the trial. Death cases will either become known during the clinical study treatment, or information will be obtained on the occasion of follow-up calls, or from e.g. treating physicians. Otherwise, patients for whom the date of death is unknown are censored at the last time point they are known to be alive.
Measured: From start of treatment until the date of death from any cause, assessed up to 4 years.
Progression free survival (PFS)
To evaluate the efficacy of Vancomycin, A/B + INTESTIFIX 001as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to Progression Free Survival (PFS).
PFS is defined as the time from start of treatment (first dose A/B) until objective tumor progression as determined by the radiologist per RECIST 1.1 or death, whichever occurs first.
Measured: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
Disease control (DC)
To evaluate the efficacy of Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to Disease Control (DC). DC is defined as achieving complete response (CR), partial response (PR) or stable disease (SD) as best overall response during observation period as determined by the radiologist per RECIST 1.1 criteria.
Measured: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
Objective Response (OR)
To evaluate the efficacy of Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to Objective Response (OR).
OR is defined as tumor size reduction, meaning PR or CR, as determined by the radiologist per RECIST 1.1 criteria assessed by best overall response during the observation period.
Measured: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
Duration of Response (DoR)
To evaluate the efficacy of Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to Duration of Response (DoR).
DoR is defined as the time from first documented response (either PR or CR per RECIST 1.1, whichever is recorded first) to first subsequent progression (first assessment of PD per RECIST 1.1 or death). DoR is only defined for the patients who experienced a response.
Measured: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
AFP serological response rate
To evaluate the efficacy Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to AFP serological response rate.
AFP serological response rate is defined as defined as a >20% de- crease in serum AFP (ng/ml)
Measured: From start until end of treatment (11 weeks).
Hepatic Function measured by model of end-stage liver disease (MELD) score
To evaluate the efficacy Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to Hepatic function measured by model of end-stage liver disease (MELD) score (Range 6-40 points, with higher points indicating worsening of function).
The hepatic function endpoints are the absolute scores at all assessed time points as well as the change to baseline.
Measured: From start until end of treatment (11 weeks).
Hepatic Function measured by Child-Pugh score
To evaluate the efficacy Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to Hepatic function measured by Child-Pugh Score (CPS) (Range 5-15, with higher scores indicating worsening).
The CPS endpoints are the absolute scores at all assessed time points as well as the change to baseline.
Measured: From start until end of treatment (11 weeks).
Hepatic Function measured by ALBI grade
To evaluate the efficacy Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to Hepatic function measured by ALBI grade (Range 1-3, with higher scores indicating worsening).
The ALBI grade endpoints are the absolute scores at all assessed time points as well as the change to baseline.
Measured: From start until end of treatment (11 weeks).
Hepatic Function measured by Psychometric Hepatic Encephalopathy Score (PHES)
To evaluate the efficacy Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo with respect to Hepatic function measured Psychometric Hepatic Encephalopathy Score (PHES) questionnaire (Range -15 tp +15, with higher scores indicating better cognitive function).
The PHES endpoints are the absolute scores at all assessed time points as well as the change to baseline.
Measured: From start until end of treatment (11 weeks).
Health-related quality of life - general
To evaluate the effect of Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo in respect to Health-related quality of life. Patient reported outcomes (PRO) via are assessed by questionnaire (EORTC QLQ-C30) and are collected during treatment. Final scores are transformed such that they range from 0 to 100, where higher scores indicate greater level of symptoms. The PRO endpoints are the absolute scores at all assessed time points as well as the change to baseline.
Measured: From start until end of treatment (11 weeks).
Health-related quality of life - disease-specific
To evaluate the effect of Vancomycin, A/B + INTESTIFIX 001 as relative to Vancomycin-placebo, A/B + INTESTIFIX 001-placebo in respect to Health-related quality of life. Patient reported outcomes (PRO) are assessed by HCC-specific questionnaire (EORTC QLQ-HCC18) and are collected during treatment. Final scores are transformed such that they range from 0 to 100, where higher scores indicate greater level of symptoms. The PRO endpoints are the absolute scores at all assessed time points as well as the change to baseline.
Measured: From start until end of treatment (11 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start16 Jul 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, randomized, placebo-controlled, double-blind, phase II with two arms (verum/placebo) in a parallel group design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Dill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Tumor Diseases, Heidelberg, German Cancer Research Center, Heidelberg University, University of Cologne, Universitätsmedizin Mannheim
- Responsible party
- Sponsor-investigator, Michael Dill, University Hospital Heidelberg
- Investigators
- Michael T Dill, PhD, Principal investigator, University Hospital Heidelberg, Heidelberg, Baden-Württemberg 69120
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690048
- Sponsor's protocol ID
- Version 3.1/11.02.2025
- Acronym
- FLORA
- Status last verified
- Aug 2025
- First submitted
- 13 Dec 2022
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Rauber C, Roberti MP, Vehreschild MJ, Tsakmaklis A, Springfeld C, Teufel A, Ettrich T, Jochheim L, Kandulski A, Missios P, Mohr R, Reichart A, Waldschmidt DT, Sauer LD, Sander A, Schirmacher P, Jager D, Michl P, Dill MT. Protocol: Faecal microbiota transfer in liver cancer to overcome resistance to atezolizumab/bevacizumab - a multicentre, randomised, placebo-controlled, double-blind phase II trial (the FLORA trial). BMJ Open. 2025 Sep 9;15(9):e097802. doi: 10.1136/bmjopen-2024-097802.
PubMed 40930564
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
- ClinicalTrials.gov ID
- NCT05690048
- Acronym / sponsor ID
- FLORA / Version 3.1/11.02.2025
- Conditions
- Immunotherapy, HCC - Hepatocellular Carcinoma
- Keywords
- immunotherapy, fecal microbiota transfer, HCC, gut microbiota, tumor microenvironment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Michael DillUniversity, hospital or other
- Collaborators
- National Center for Tumor Diseases, Heidelberg, German Cancer Research Center, Heidelberg University, University of Cologne, Universitätsmedizin Mannheim
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible HCC patients visiting the outpatient clinics at the study sites of the NCT Germany will be enrolled into the study after informed consent. Patients undergo 2:1 randomization into either the FMT or placebo group. Prior to the intervention, a sigmoidoscopy with mucosal biopsies will be performed. At day -3 to 0 oral Vancomycin 4x 250mg or placebo will be given. Atezolizumab/bevacizumab (A/B) will be administered as standard of care every 21 days, starting on day 0. At day 0 and 21, concurrent to the first and second cycle of A/B, encapsulated FMT or placebo will be administered on the same day. At day 40-42, before the third cycle of A/B, a tumor biopsy and a sigmoidoscopy will be performed. The first radiologic assessment will be performed after 4 cycles of A/B. Clinical efficacy and safety will be assessed as indicated per protocol analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional, randomized, placebo-controlled, double-blind, phase II with two arms (verum/placebo) in a parallel group design
| Arm | Type | Receives |
|---|---|---|
| Vancomycin + A/B + FMT | Experimental | Drug: Fecal microbiota transfer, Drug: Vancomycin Oral Capsule, Drug: Atezolizumab + Bevacizumab1. Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC). 2. Vancomycin orally (250 mg 4xd, day -3 to 0) for reduction of original patient gut microbiota. 3. Fecal microbiota transfer (FMT) via capsules (total 50 g of fecal matter) on day 0 and day 21. |
| Placebo Vancomycin + A/B + Placebo FMT | Placebo comparator | Drug: Atezolizumab + Bevacizumab, Drug: Placebo Vancomycin Oral Capsule, Drug: Placebo Fecal microbiota transfer1. Atezolizumab 1200mg i.v. \& bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC). 2. Placebo vancomycin orally (4xd, day -3 to 0) for reduction of original patient gut microbiota. 3. Placebo fecal microbiota transfer (FMT) via capsules on day 0 and day 21. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Confirmed radiologic or histological diagnosis of HCC
- Disease not amenable to resection, liver transplantation or loco-regionary therapy
- Eligible for therapy with Atezolizumab / Bevacizumab according to standard of care
- Measurable disease per RECIST 1.1
Key exclusion criteria (20 listed)
- Use of immunosuppressive medication within 6 months prior to the first dose of Atezolizumab / Bevacizumab.
- Active or prior documented autoimmune or inflammatory disorders
- 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.
- Known to have tested positive for human immunodeficiency virus (HIV) infection.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transferAlso: FMT, INTESTIFIX 001FMT via capsule (50 g of fecal matter) on day 0 and day 21. | Drug | Vancomycin + A/B + FMT |
| Vancomycin Oral CapsuleVancomycin orally (250 mg 4xd, day -3 to 0). | Drug | Vancomycin + A/B + FMT |
| Atezolizumab + BevacizumabAlso: A/BAtezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC). | Drug | Placebo Vancomycin + A/B + Placebo FMT, Vancomycin + A/B + FMT |
| Placebo Vancomycin Oral CapsulePlacebo Vancomycin orally (4xd, day -3 to 0). | Drug | Placebo Vancomycin + A/B + Placebo FMT |
| Placebo Fecal microbiota transferAlso: Placebo FMT, Placebo INTESTIFIX 001Placebo Fecal microbiota transfer (FMT) via capsule on day 0 and day 21. | Drug | Placebo Vancomycin + A/B + Placebo FMT |
Primary outcome
Assessment of immunogenicity
Time frame: 6 weeks after treatment initiation
Tumoral CD8+ T cell infiltration after 2 cycles of treatment with Vancomycin, A/B + FMT in comparison to Vancomycin-placebo, A/B + FMT-placebo
Safety of the therapeutic combination in advanced HCC
Time frame: The observational period begins with the first administration of the 1st IMP (Vancomycin/Placebo) on day -3 and ends with either the Follow-up visit after 15 weeks (Day 105) or the initiation of a subsequent anticancer treatment.
Occurence of Adverse Events (AE) \& immune-related adverse events (irAE)
12 secondary outcomes
Overall survival (OS)
Time frame: From start of treatment until the date of death from any cause, assessed up to 4 years.
Progression free survival (PFS)
Time frame: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
Disease control (DC)
Time frame: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
Objective Response (OR)
Time frame: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
Duration of Response (DoR)
Time frame: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
AFP serological response rate
Time frame: From start until end of treatment (11 weeks).
Hepatic Function measured by model of end-stage liver disease (MELD) score
Time frame: From start until end of treatment (11 weeks).
Hepatic Function measured by Child-Pugh score
Time frame: From start until end of treatment (11 weeks).
Hepatic Function measured by ALBI grade
Time frame: From start until end of treatment (11 weeks).
Hepatic Function measured by Psychometric Hepatic Encephalopathy Score (PHES)
Time frame: From start until end of treatment (11 weeks).
Health-related quality of life - general
Time frame: From start until end of treatment (11 weeks).
Health-related quality of life - disease-specific
Time frame: From start until end of treatment (11 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Derived from this study: PubMed 40930564Rauber C, Roberti MP, Vehreschild MJ, Tsakmaklis A, Springfeld C, Teufel A, Ettrich T, Jochheim L, Kandulski A, Missios P, Mohr R, Reichart A, Waldschmidt DT, Sauer LD, Sander A, Schirmacher P, Jager D, Michl P, Dill MT. Protocol: Faecal microbiota transfer in liver cancer to overcome resistance to atezolizumab/bevacizumab - a multicentre, randomised, placebo-controlled, double-blind phase II trial (the FLORA trial). BMJ Open. 2025 Sep 9;15(9):e097802. doi: 10.1136/bmjopen-2024-097802.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael T Dill, PhD principal investigator
University Hospital Heidelberg, Heidelberg, Baden-Württemberg 69120
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal microbiota transfer, Vancomycin Oral Capsule and Atezolizumab + Bevacizumab in people with Immunotherapy and HCC - Hepatocellular Carcinoma, run by Michael Dill at 7 sites in Germany.
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 7 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael T Dill, PhD (06221 568611, michael.dill@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of immunogenicity (time frame: 6 weeks after treatment initiation). The study lists 2 primary outcomes in all. 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 NCT05690048, 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 Aug 2025.