Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690048
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-23
First Post:
2022-12-13
Brief Title:
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to AtezolizumabBevacizumab FLORA
Sponsor:
Michael Dill
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to AtezolizumabBevacizumab FLORA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLORA
Brief 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 21 into either the FMT or placebo group
Subjects will be randomized 21 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 21 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 AB will begin within five working days after sigmoidoscopy AB 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 AB encapsulated FMT will be administered on the same day At day 40-42 before the third cycle of AB 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None