NCT07193316Completed
Safety and Efficacy of Atezolizumab-Bevacizumab Versus Tyrosin Kinase Inhibitors in Patients With Liver Cirrhosis
Real Life Safety and Efficacy of Atezolizumab-Bevacizumab Versus Tyrosin Kinase Inhibitors in Patients With Liver Cirrhosis
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 38 (actual)
- First submitted
- 5 Apr 2024
- Start date
- 27 Jul 2023
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07193316
What you commit to
- Study type: Observational
- Participants enrolled: 38
- From 27 Jul 2023 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- age \< 18 years old
Other
- patients without HCC or with HCC eligible for curative or locoregional treatments
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Agostino Gemelli, IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.