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

NCT06416683 | Completed

• 1 other identifier: ABCHCaen
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atezolizumab and Bevacizumab in Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival in patients with hepatocellular carcinoma

  3 years

Secondary Outcomes (3)

• progression-free survival

  3 years

• predictors of response to treatment

  3 years

• treatment tolerance

  3 years

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• patients with another kind of liver cancer

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen

Caen, France/Normandie, 14000, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: January 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: January 30, 2024
• Last Updated: March 26, 2025

Record last verified: 2024-05

Locations

FR (1)