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Completed

NCT Number: NCT06416683

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 3 years

    Overall survival in patients with hepatocellular carcinoma

Secondary outcomes

  1. progression-free survival

    Time frame: 3 years

    progression-free survival in patients with hepatocellular carcinoma

  2. predictors of response to treatment

    Time frame: 3 years

    predictors of response to Atézolizumab and Bevacizumab

  3. treatment tolerance

    Time frame: 3 years

    treatment tolerance to Atézolizumab and Bevacizumab

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: ABCHCaen

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 16, 2024
Registry last updated
Mar 26, 2025

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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