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Trial Title:
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
NCT ID:
NCT05690048
Condition:
Immunotherapy
Conditions: Official terms:
Liver Neoplasms
Vancomycin
Bevacizumab
Atezolizumab
Conditions: Keywords:
immunotherapy
fecal microbiota transfer
HCC
gut microbiota
tumor microenvironment
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Interventional, randomized, controlled, single blind trial phase II with two arms
(verum/placebo) in a parallel group design
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Fecal microbiota transfer
Description:
FMT via capsule (50 g of fecal matter) on day 0 and day 21.
Arm group label:
Vancomycin + A/B + FMT
Other name:
FMT
Intervention type:
Drug
Intervention name:
Vancomycin Oral Capsule
Description:
Vancomycin orally (125 mg 4xd, day -3 to 0).
Arm group label:
Vancomycin + A/B + FMT
Intervention type:
Drug
Intervention name:
Atezolizumab + Bevacizumab
Description:
Atezolizumab 1200mg i.v. & Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care
(SOC).
Arm group label:
Placebo Vancomycin + A/B + Placebo FMT
Arm group label:
Vancomycin + A/B + FMT
Other name:
A/B
Intervention type:
Drug
Intervention name:
Placebo Vancomycin Oral Capsule
Description:
Placebo Vancomycin orally (125 mg 4xd, day -3 to 0).
Arm group label:
Placebo Vancomycin + A/B + Placebo FMT
Intervention type:
Drug
Intervention name:
Placebo Fecal microbiota transfer
Description:
Placebo Fecal microbiota transfer (FMT) via capsule (50 g of fecal matter) on day 0 and
day 21.
Arm group label:
Placebo Vancomycin + A/B + Placebo FMT
Summary:
The interventional, randomized, placebo-controlled, single 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 of LCCH at the study sites at NCT
Heidelberg and University Medical Center Mannheim will be enrolled into the study after
informed consent. Patients undergo 2:1 randomization into either the FMT or placebo
group. Study lead in with a first sonographically guided tumor biopsy, if not already
performed for diagnostic purposes, and a sigmoidoscopy will be scheduled within 10 days
after study enrollment in an outpatient setting. Start of active pharmacotherapy with A/B
will begin within five working days after sigmoidoscopy. A/B administration will be
administered as standard of care every 21 days. At day -3 to 0 oral Vancomycin will be
given 4x 250mg to the verum group. At day 0 and 21, concurrent to the first and second
cycle of A/B, encapsulated FMT will be administered on the same day. At day 40-42, before
the third cycle of A/B, a second biopsy of the liver lesion and a sigmoidoscopy will be
performed. Clinical efficacy and safety will be assessed as indicated per protocol
analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 years or older
2. Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium C
3. ECOG performance status of 0-1
Exclusion Criteria:
1. Advanced liver cirrhosis (Child-Pugh Score C)
2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
3. Usage of antibiotics within 2 weeks prior enrollment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Contact:
Last name:
Michael Dill, PhD
Contact backup:
Last name:
Conrad Rauber, PhD
Facility:
Name:
University Hospital Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Start date:
January 1, 2024
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Michael Dill
Agency class:
Other
Collaborator:
Agency:
National Center for Tumor Diseases, Heidelberg
Agency class:
Other
Collaborator:
Agency:
German Cancer Research Center
Agency class:
Other
Collaborator:
Agency:
Heidelberg University
Agency class:
Other
Collaborator:
Agency:
University of Cologne
Agency class:
Other
Collaborator:
Agency:
Universitätsmedizin Mannheim
Agency class:
Other
Source:
University Hospital Heidelberg
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05690048
