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

NCT07193316 | Completed

• 1 other identifier: 5890
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Liver Cirrhosis

Keywords

hepatocellular carcinoma; atezolizumab bevacizumab

Outcome Measures

Primary Outcomes (1)

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

  efficacy and safety of atezolizumab bevacizumab in terms of overall survival

  2 years

Secondary Outcomes (2)

• time under treatment

  2 years

• time to decompensation

  2 years

Study Arms (2)

patients receiving atezolizumab/bevacizumab

247 patients with advanced HCC that received Atezolizumab Bevacizumab

Other: no intervention

patients receiving tyrosine kinase inhibitors

494 patients treated with Sorafenib or Lenvatinib per advanced HCC

Other: no intervention

Interventions

no intervention OTHER

no intervention

patients receiving atezolizumab/bevacizumab; patients receiving tyrosine kinase inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• age \< 18 years old
• patients without HCC or with HCC eligible for curative or locoregional treatments

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

Related Publications (1)

• Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.

  PMID: 32402160 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: September 25, 2025
• Study Start: July 27, 2023
• Primary Completion: October 31, 2024
• Study Completion: September 25, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)