ATEZOLIZUMAB - BEVACIZUMAB in the Treatment Hepatocellular Carcinoma Inoperable or (HEPATOFIT)
January 26, 2021 updated by: University Hospital, Brest
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
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hepatocellular carcinoma locally advanced or metastatic in first line of systemic treatment
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- refuse to participate
- under legal protection
- exclusion criteria from the tempory utilisation authorization
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 |
|---|---|---|
|
predictive factor for progression-free survival
Time Frame: 12 months
|
progression-free survival = time between treatment initiation and rediologic or clinical progression
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
January 18, 2021
Primary Completion (Anticipated)
January 18, 2022
Study Completion (Anticipated)
January 18, 2022
Study Registration Dates
First Submitted
January 26, 2021
First Submitted That Met QC Criteria
January 26, 2021
First Posted (Actual)
January 29, 2021
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC20.0325
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.