unresectable hepatocellular carcinoma
Conditions
Brief summary
Progression-Free Survival (PFS), defined as the time from randomization to the occurrence of disease progression or death from any cause, whichever occurs first. Progression events will be considered based on centralized tumor response assessment according to RECIST version 1.1 and PFS analyses will be performed by the CHU Grenoble Alpes Statistics department.
Detailed description
To assess the tumor response under the association of Ezurpimtrostat with Atezolizumab-Bevacizumab in first line setting in unresectable hepatocellular carcinoma, To assess the impact of the association Ezurpimtrostat + Atezolizumab-Bevacizumab on Overall Survival (OS), To assess the duration of response of the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the Alpha-fetoprotein (AFP) response at 3, 6, 12 months under the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the overall survival rate at 6, 12-months under the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the progression free survival rate at 6, 12-months under the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the safety of the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the Quality of life (by EORTC QLQ-C30 score) and the time to deterioration (TTD) under the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the predictive value of CD4/CD8 intratumor infiltrate on tumor response and survival outcomes, To assess the predictive value of PPT1 baseline expression on tumor response and survival outcomes, Pharmacokinetic (PK) and pharmacodynamics (PD) study of Ezurpimtrostat in association with Atezolizumab-Bevacizumab, Peripheral blood mononuclear cell (PBMC) biobanking for further ancillary studies
Interventions
Sponsors
Centre Hospitalier Universitaire De Grenoble
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS), defined as the time from randomization to the occurrence of disease progression or death from any cause, whichever occurs first. Progression events will be considered based on centralized tumor response assessment according to RECIST version 1.1 and PFS analyses will be performed by the CHU Grenoble Alpes Statistics department. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the tumor response under the association of Ezurpimtrostat with Atezolizumab-Bevacizumab in first line setting in unresectable hepatocellular carcinoma, To assess the impact of the association Ezurpimtrostat + Atezolizumab-Bevacizumab on Overall Survival (OS), To assess the duration of response of the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the Alpha-fetoprotein (AFP) response at 3, 6, 12 months under the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the overall survival rate at 6, 12-months under the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the progression free survival rate at 6, 12-months under the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the safety of the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the Quality of life (by EORTC QLQ-C30 score) and the time to deterioration (TTD) under the association Ezurpimtrostat + Atezolizumab-Bevacizumab, To assess the predi | — |
Countries
France
Outcome results
None listed