NCT04730388

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

January 26, 2021

Last Update Submit

January 26, 2021

Conditions

Advanced Hepatocellular Carcinoma

Keywords

ATEZOLIZUMAB, BEVACIZUMAB , Advanced hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • predictive factor for progression-free survival

    progression-free survival = time between treatment initiation and rediologic or clinical progression

    12 months

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • refuse to participate
  • under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Pierre-Guillaume Poureau, MD

CONTACT

0298223740pierre-guillaume.poureau@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

January 29, 2021

Study Start

January 18, 2021

Primary Completion

January 18, 2022

Study Completion

January 18, 2022

Last Updated

January 29, 2021

Record last verified: 2021-01