Hepatocellular Carcinoma, Liver Cirrhosis
Conditions
Keywords
hepatocellular carcinoma, atezolizumab bevacizumab
Brief summary
Following the results of the randomized clinical trial IMbrave150, the combination of Atezolizumab with Bevacizumab became the first line regimen for patients with advanced hepatocellular carcinoma and it was approved by the FDA and the EMA. Despite these results, real life data on safety and efficacy of this therapy are still lacking. The unmet needs currently observed are: the safety and efficacy in patients with mild liver decompensation (Child Pugh B class) detected before or during treatment start and the role of liver decompensation compared to TKIs therapy. Liver decompensation is not necessary associated with tumor progression and it may occur in patients with liver cirrhosis. Its prognostic role is not known. in this multicentric observational study the Authors enrolled patients with liver cirrhosis and advanced hepatocellular carcinoma treated with Atezolizumab/Bevacizumab to analyse efficacy, safety compared to a retrospectively collected matched cohort of patients treated with TKIs. Moreover They evaluated the safety and efficacy of Atezolizumab/Bevacizumab according to liver function (detected as Child Pugh score and Albumin-Bilirubin grade), underlying etiology of liver disease, presence or absence of portal hypertension and finally presence or absence of liver decompensation. Furthermore, the Authors evaluated its prognostic role on overall survival and time to progression.
Detailed description
Following the results of the randomized clinical trial IMbrave150, the combination of Atezolizumab with Bevacizumab became the first line regimen for patients with advanced hepatocellular carcinoma and it was approved by the FDA and the EMA. Despite these results, real life data on safety and efficacy of this therapy are still lacking. The unmet needs currently observed are: the safety and efficacy in patients with mild liver decompensation (Child Pugh B class) detected before or during treatment start and the role of liver decompensation compared to TKIs therapy. Liver decompensation is not necessary associated with tumor progression and it may occur in patients with liver cirrhosis. Its prognostic role is not known. in this multicentric observational study the Authors enrolled patients with liver cirrhosis and advanced hepatocellular carcinoma treated with Atezolizumab/Bevacizumab to analyse the safety and efficacy compared to a retrospectively collected matched cohort of patients treated with TKIs. Moreover they evaluated the safety and efficacy of Atezolizumab/Bevacizumab according to liver function (detected as Child Pugh score and Albumin-Bilirubin grade), underlying etiology of liver disease, presence or absence of portal hypertension and finally presence or absence of liver decompensation. Furthermore, they evaluated its prognostic role on overall survival and time to progression.
Interventions
OTHERno intervention
no intervention
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
patients with liver cirrhosis (Child Pugh A or Child Pugh B) and advanced HCC eligible for systemic therapy * radiological or histological diagnosis of HCC * age \> 18 years old
Exclusion criteria
* age \< 18 years old * patients without HCC or with HCC eligible for curative or locoregional treatments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and safety of Atezolizumab Bevacizumab in terms of overall survival (OS) compard to TKIs. | 2 years | efficacy and safety of atezolizumab bevacizumab in terms of overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time under treatment | 2 years | time from the start of treatment to the end of treatment due to any cause |
| time to decompensation | 2 years | time from the start of treatment to occurrence of liver decompensation (ascites, bleeding due to portal hypertension, hyperbilirubinemia, hepatic encephalopathy) |
Countries
Italy
Outcome results
None listed