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

University Hospital, Brest

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

Keywords

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.

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