Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab – A randomized, placebo-controlled, double-blind Phase II trial (FLORA)

Conditions

Hepatocellular carcinoma

Brief summary

The primary immunological patient variable is the count of tumor-infiltrating CD8+ T lymphocytes in the tumor biopsy after two cycles of A/B (d38). CD8+T lymphocyte density will be quantitatively assessed after manual delineation of tumor area in the biopsy (count of CD8+ cells per square millimeter tumor area). Tumor areas with crush artifacts or necrosis will be excluded from analysis., Incidence and severity of AEs and SAEs from treatment start until 42 days after the fourth cycle of A/B (d105). The occurrence of AEs and SAEs is assessed for each patient, including incidence, severity, timing, seriousness, relatedness to study treatment, action taken with study medication and outcome. Detailed information is provided in section 8.

Conrad Rauber, María Paula Roberti, Maria J. G. T. Vehreschild, Anastasia Tsakmaklis, Christoph Springfeld et al. (19 authors)

BMJ Open2025-09-012 citations

10.1136/bmjopen-2024-097802

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGATEZOLIZUMAB

DRUGBEVACIZUMAB

DRUGINTESTIFIX 001

DRUGIntestifix 001 placebo

DRUGVancomycin ENTEROCAPS® 250 mg

DRUGHartkapseln

DRUGVancomycin Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary immunological patient variable is the count of tumor-infiltrating CD8+ T lymphocytes in the tumor biopsy after two cycles of A/B (d38). CD8+T lymphocyte density will be quantitatively assessed after manual delineation of tumor area in the biopsy (count of CD8+ cells per square millimeter tumor area). Tumor areas with crush artifacts or necrosis will be excluded from analysis., Incidence and severity of AEs and SAEs from treatment start until 42 days after the fourth cycle of A/B (d105). The occurrence of AEs and SAEs is assessed for each patient, including incidence, severity, timing, seriousness, relatedness to study treatment, action taken with study medication and outcome. Detailed information is provided in section 8.	—

Measure

Time frame

The primary immunological patient variable is the count of tumor-infiltrating CD8+ T lymphocytes in the tumor biopsy after two cycles of A/B (d38). CD8+T lymphocyte density will be quantitatively assessed after manual delineation of tumor area in the biopsy (count of CD8+ cells per square millimeter tumor area). Tumor areas with crush artifacts or necrosis will be excluded from analysis., Incidence and severity of AEs and SAEs from treatment start until 42 days after the fourth cycle of A/B (d105). The occurrence of AEs and SAEs is assessed for each patient, including incidence, severity, timing, seriousness, relatedness to study treatment, action taken with study medication and outcome. Detailed information is provided in section 8.

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Countries

Germany

Outcome results

None listed