Atezolizumab and Bevacizumab in Hepatocellular CarcinomaABCHCaenNCT06416683
Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma (ABCHCaen)
An observational study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atezolizumab and Bevacizumab in Hepatocellular Carcinoma
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 30 Jan 2024
- 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 advanced hepatocellular carcinoma whose treatment with Atezolizumab and Bevacizumab has been validated in a multidisciplinary consultation meeting
Who may be able to join
- age superior or equal to 18 years
- patients with advanced hepatocellular carcinoma
- treatment validated in multidisciplinary consultation meeting
Who cannot join
- patients with another kind of liver cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- hepatocellular carcinoma, immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival in patients with hepatocellular carcinoma
Measured: 3 years
Secondary outcomes (3)
progression-free survival
progression-free survival in patients with hepatocellular carcinoma
Measured: 3 years
predictors of response to treatment
predictors of response to Atézolizumab and Bevacizumab
Measured: 3 years
treatment tolerance
treatment tolerance to Atézolizumab and Bevacizumab
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jan 2021
- Primary completion30 Jun 2023
- Study completion30 Jan 2024
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 Atezolizumab and Bevacizumab in Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416683
- Sponsor's protocol ID
- ABCHCaen
- Acronym
- ABCHCaen
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Metivier C, Campani C, Allaire M, Morello R, Mouri S, Spitzer E, Bouattour M, Hollande C, Sidali S, Nault JC, Ganne-Carrie N, Nahon P, Amaddeo G, Regnault H, Vigneron P, Peron JM, Sadek L, Cussac C, Lequoy M, Ozenne V, Galais MP, Perignon C, Lebedel L, Habireche M, Commin A, Dao T, Costentin C, Baron A, Hourmand IO. Atezolizumab-bevacizumab in very elderly with hepatocellular carcinoma: Age alone is not a limiting factor except in ALBI grade 3. JHEP Rep. 2026 Jun;8(6):101827. doi: 10.1016/j.jhepr.2026.101827. Epub 2026 Mar 17.
PubMed 41856249
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT06416683
- Acronym / sponsor ID
- ABCHCaen / ABCHCaen
- Keywords
- hepatocellular carcinoma, immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 16 May 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with advanced hepatocellular carcinoma whose treatment with Atezolizumab and Bevacizumab has been validated in a multidisciplinary consultation meeting
Key inclusion criteria (3 listed)
- age superior or equal to 18 years
- patients with advanced hepatocellular carcinoma
- treatment validated in multidisciplinary consultation meeting
Key exclusion criteria (1 listed)
- patients with another kind of liver cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 3 years
Overall survival in patients with hepatocellular carcinoma
3 secondary outcomes
progression-free survival
Time frame: 3 years
predictors of response to treatment
Time frame: 3 years
treatment tolerance
Time frame: 3 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 26 Mar 2025.
- Derived from this study: PubMed 41856249Metivier C, Campani C, Allaire M, Morello R, Mouri S, Spitzer E, Bouattour M, Hollande C, Sidali S, Nault JC, Ganne-Carrie N, Nahon P, Amaddeo G, Regnault H, Vigneron P, Peron JM, Sadek L, Cussac C, Lequoy M, Ozenne V, Galais MP, Perignon C, Lebedel L, Habireche M, Commin A, Dao T, Costentin C, Baron A, Hourmand IO. Atezolizumab-bevacizumab in very elderly with hepatocellular carcinoma: Age alone is not a limiting factor except in ALBI grade 3. JHEP Rep. 2026 Jun;8(6):101827. doi: 10.1016/j.jhepr.2026.101827. Epub 2026 Mar 17.
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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 Atezolizumab and Bevacizumab in Hepatocellular Carcinoma, run by University Hospital, Caen at 1 site in France.
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 1 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 26 Mar 2025. 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 France. 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?
Overall survival (time frame: 3 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 NCT06416683, 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 26 Mar 2025.