Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma (ABCHCaen) (ABCHCaen)

May 11, 2024 updated by: Isabelle OLLIVIER, University Hospital, Caen

Study of the Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma.

In France primary liver cancers (PLC) is the fourth leading cause of cancer-related death in men, and the seventh in women. The number of new cases per year is predicted to increase by 26.5% between 2020 and 2040. Hepatocellular carcinoma (HCC) account for 75% to 85% of PLC. It occurs mostly on cirrhotic livers. Diagnosis remains late in almost half of the patients so that a palliatif treatment is frequent. In advanced cases sorafenib has been so far the first line systemic therapy since 2008. In 2020 a phase 3 study has demonstrated a better overall survival in patients treated with bevacizumab associated with atezolizumab as compared to sorafenib (19.2 months vs 13.4 months) and a better quality of life. Noweday immunotherapy is recommended in first line in cases of ECOG 0/1 unresectable HCC without liver insufficiency. However the study included 70% of viral liver diseases while HCC are related to alcohol and steatohepatitis in 50% of cases in France. Moreover patients with high risk of oesophageal variceal bleeding were excluded. Recent real life data published worldwide confirm the bitherapy efficacy and good tolerability. By contrast french data are scarces, with a single serie of 43 patients in which median overall survival was estimated to 12 months. Our main aim is to determine the overall survival of HCC patients treated with atezolizumab and bevacizumab in Caen from april 2021.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • France/Normandie
      • Caen, France/Normandie, France, 14000
        • CHU de Caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with advanced hepatocellular carcinoma whose treatment with Atezolizumab and Bevacizumab has been validated in a multidisciplinary consultation meeting

Description

Inclusion Criteria:

  • age superior or equal to 18 years
  • patients with advanced hepatocellular carcinoma
  • treatment validated in multidisciplinary consultation meeting

Exclusion Criteria:

  • patients with another kind of liver cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
Overall survival in patients with hepatocellular carcinoma
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 3 years
progression-free survival in patients with hepatocellular carcinoma
3 years
predictors of response to treatment
Time Frame: 3 years
predictors of response to Atézolizumab and Bevacizumab
3 years
treatment tolerance
Time Frame: 3 years
treatment tolerance to Atézolizumab and Bevacizumab
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

May 11, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCHCaen

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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