Advanced Hepatocellular CarcinomaHEPATOFITNCT04730388
ATEZOLIZUMAB - BEVACIZUMAB in the Treatment Hepatocellular Carcinoma Inoperable or
An observational study of Advanced Hepatocellular Carcinoma, run by University Hospital, Brest.
Trial summary
Evaluation of the efficacy and safety of the combination ATEZOLIZUMAB - BEVACIZUMAB in the treatment of locally advanced inoperable or metastatic hepatocellular carcinoma in Finistère Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2021to 18 Jan 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatocellular carcinoma locally advanced or metastatic in first line of systemic treatment
Who may be able to join
- hepatocellular carcinoma locally advanced or metastatic, non able to be resectable, with no prior systemic treatment
- Child Pugh A and ECOG 0 or 1
- upper digestiuve endoscopy less than 6 months, if esophageal varcices : must be treated
- non eligible to receive a locoregional therpay or progressive after this kinf of treatment
- with informed consent
Who cannot join
- refuse to participate
- under legal protection
- exclusion criteria from the tempory utilisation authorization
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Efficacy and Tolerance of the Association ATEZOLIZUMAB - BEVACIZUMAB in the Treatment of a Locally Advanced Hepatocellular Carcinoma Inoperable or Metastatic in Finistère
Evaluation of the efficacy and safety of the combination ATEZOLIZUMAB - BEVACIZUMAB in the treatment of locally advanced inoperable or metastatic hepatocellular carcinoma in Finistère
Read the detailed description
Patients treated by ATEZOLIZUMAB and BEVACIZUMAB for an Advanced hepatocellular carcinoma will be followed to observed their safety and the efficacy of this treatment, and to identify prongnosis factors
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- ATEZOLIZUMAB, BEVACIZUMAB , Advanced hepatocellular carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive factor for progression-free survival
progression-free survival = time between treatment initiation and rediologic or clinical progression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start18 Jan 2021 (estimated)
- Primary completion18 Jan 2022 (estimated)
- Study completion18 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730388
- Sponsor's protocol ID
- 29BRC20.0325
- Acronym
- HEPATOFIT
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerance of the Association ATEZOLIZUMAB - BEVACIZUMAB in the Treatment of a Locally Advanced Hepatocellular Carcinoma Inoperable or Metastatic in Finistère
- ClinicalTrials.gov ID
- NCT04730388
- Acronym / sponsor ID
- HEPATOFIT / 29BRC20.0325
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- ATEZOLIZUMAB, BEVACIZUMAB , Advanced hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Jan 2021 (estimated)
- Primary completion
- 18 Jan 2022 (estimated)
- Study completion
- 18 Jan 2022 (estimated)
- First posted
- 29 Jan 2021 (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.
Evaluation of the efficacy and safety of the combination ATEZOLIZUMAB - BEVACIZUMAB in the treatment of locally advanced inoperable or metastatic hepatocellular carcinoma in Finistère
Detailed description
Patients treated by ATEZOLIZUMAB and BEVACIZUMAB for an Advanced hepatocellular carcinoma will be followed to observed their safety and the efficacy of this treatment, and to identify prongnosis factors
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatocellular carcinoma locally advanced or metastatic in first line of systemic treatment
Key inclusion criteria (5 listed)
- hepatocellular carcinoma locally advanced or metastatic, non able to be resectable, with no prior systemic treatment
- Child Pugh A and ECOG 0 or 1
- upper digestiuve endoscopy less than 6 months, if esophageal varcices : must be treated
- non eligible to receive a locoregional therpay or progressive after this kinf of treatment
- with informed consent
Key exclusion criteria (3 listed)
- refuse to participate
- under legal protection
- exclusion criteria from the tempory utilisation authorization
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
predictive factor for progression-free survival
Time frame: 12 months
progression-free survival = time between treatment initiation and rediologic or clinical progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Hepatocellular Carcinoma, run by University Hospital, Brest.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Guillaume Poureau, MD (0298223740, pierre-guillaume.poureau@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive factor for progression-free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2021.