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Completed

NCT Number: NCT07193316

Safety and Efficacy of Atezolizumab-Bevacizumab Versus Tyrosin Kinase Inhibitors in Patients With Liver Cirrhosis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Efficacy and safety of Atezolizumab Bevacizumab in terms of overall survival (OS) compard to TKIs.

    Time frame: 2 years

    efficacy and safety of atezolizumab bevacizumab in terms of overall survival

Secondary outcomes

  1. time under treatment

    Time frame: 2 years

    time from the start of treatment to the end of treatment due to any cause

  2. time to decompensation

    Time frame: 2 years

    time from the start of treatment to occurrence of liver decompensation (ascites, bleeding due to portal hypertension, hyperbilirubinemia, hepatic encephalopathy)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Real Life Safety and Efficacy of Atezolizumab-Bevacizumab Versus Tyrosin Kinase Inhibitors in Patients With Liver Cirrhosis

Acronym: SEEK

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 25, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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