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NCT04730388 Clinical Trial

ATEZOLIZUMAB - BEVACIZUMAB in the Treatment Hepatocellular Carcinoma Inoperable or

Advanced Hepatocellular Carcinoma Clinical Trial

— HEPATOFIT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04730388
Other study ID # 29BRC20.0325
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 18, 2021
Est. completion date January 18, 2022

Study information
Verified date January 2021
Source University Hospital, Brest
Contact Pierre-Guillaume Poureau, MD
Phone 0298223740
Email pierre-guillaume.poureau@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date January 18, 2022
Est. primary completion date January 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Outcome
Type Measure Description Time frame Safety issue
Primary predictive factor for progression-free survival progression-free survival = time between treatment initiation and rediologic or clinical progression 12 months
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