Hepatocellular CarcinomaSEEKNCT07193316
Safety and Efficacy of Atezolizumab-Bevacizumab Versus Tyrosin Kinase Inhibitors in Patients With Liver Cirrhosis
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jul 2023to 25 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- age < 18 years old
- patients without HCC or with HCC eligible for curative or locoregional treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real Life 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Being tested
- no intervention
- Keywords
- hepatocellular carcinoma, atezolizumab bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| patients receiving atezolizumab/bevacizumab | 247 patients with advanced HCC that received Atezolizumab Bevacizumab Receives: Other: no intervention | |
| patients receiving tyrosine kinase inhibitors | 494 patients treated with Sorafenib or Lenvatinib per advanced HCC Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
time under treatment
time from the start of treatment to the end of treatment due to any cause
Measured: 2 years
time to decompensation
time from the start of treatment to occurrence of liver decompensation (ascites, bleeding due to portal hypertension, hyperbilirubinemia, hepatic encephalopathy)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start27 Jul 2023
- Primary completion31 Oct 2024
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ponziani Francesca Romana, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193316
- Sponsor's protocol ID
- 5890
- Acronym
- SEEK
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32402160
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Safety and Efficacy of Atezolizumab-Bevacizumab Versus Tyrosin Kinase Inhibitors in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT07193316
- Acronym / sponsor ID
- SEEK / 5890
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis
- Keywords
- hepatocellular carcinoma, atezolizumab bevacizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients receiving atezolizumab/bevacizumab | – | Other: no intervention247 patients with advanced HCC that received Atezolizumab Bevacizumab |
| patients receiving tyrosine kinase inhibitors | – | Other: no intervention494 patients treated with Sorafenib or Lenvatinib per advanced HCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- age < 18 years old
- patients without HCC or with HCC eligible for curative or locoregional treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | patients receiving atezolizumab/bevacizumab, patients receiving tyrosine kinase inhibitors |
Primary outcome
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
2 secondary outcomes
time under treatment
Time frame: 2 years
time to decompensation
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 32402160Finn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and safety of Atezolizumab Bevacizumab in terms of overall survival (OS) compard to TKIs. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07193316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.