unresectable hepatocellular carcinoma (HCC)
Conditions
Brief summary
The primary endpoints of the study are - for safety: incidence of adverse events of grade > 3 - for efficacy: disease control rate (according to RECIST 1.1) at 12 weeks after FMT. Disease control is defined as complete response, partial response and stable disease.
Detailed description
Characterization of patients’ microbiota both before and after FMT in terms of diversity and abundance of different microbiomal populations, Blood biomarkers: characterization of neutrophil and lymphocytic populations in terms of PD-1 PD-L1 expression, Neutrophil and Lymphocytes ratios, markers of inflammation (C-reactive proteins), LDH, RNAseq patterns
Interventions
DRUGZENGAC “500 mg Polvere per soluzione per infusione e per uso orale”
DRUGPlenvu
DRUGpolvere per soluzione orale
DRUGSELG ESSE polvere per soluzione orale
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGVancomicina Mylan 500 mg polvere per soluzione per infusione
Sponsors
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Characterization of patients’ microbiota both before and after FMT in terms of diversity and abundance of different microbiomal populations, Blood biomarkers: characterization of neutrophil and lymphocytic populations in terms of PD-1 PD-L1 expression, Neutrophil and Lymphocytes ratios, markers of inflammation (C-reactive proteins), LDH, RNAseq patterns | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study are - for safety: incidence of adverse events of grade > 3 - for efficacy: disease control rate (according to RECIST 1.1) at 12 weeks after FMT. Disease control is defined as complete response, partial response and stable disease. | — |
Countries
Italy
Outcome results
None listed