ATEZOLIZUMAB - BEVACIZUMAB in the Treatment Hepatocellula... | NCT04730388

Studies
ATEZOLIZUMAB - BEVACIZUMAB in the Treatment Hepatocellular Carcinoma Inoperable or

NCT04730388

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Jan 29, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Advanced Hepatocellular Carcinoma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 18, 2021Estimated

Primary Completion Date

Jan 18, 2022Estimated

Completion Date

Jan 18, 2022Estimated

First Submitted Date

Jan 26, 2021

First Submission Date that Met QC Criteria

Jan 26, 2021

First Posted Date

Jan 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2021

Last Update Posted Date

Jan 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
predictive factor for progression-free survival	progression-free survival = time between treatment initiation and rediologic or clinical progression	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Hepatocellular carcinoma locally advanced or metastatic in first line of systemic treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pierre-Guillaume Poureau, MD	Contact	0298223740		pierre-guillaume.poureau@chu-brest.fr

Overall Officials

Not provided

Locations

Not provided