Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04803994
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2021-03-15
Brief Title:
The ABC-HCC Trial Atezolizumab Plus Bevacizumab vs Transarterial Chemoembolization TACE in Intermediate-stage HepatoCellular Carcinoma
Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Organization:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study Overview
Official Title:
The ABC-HCC Trial A Phase IIIb Randomized Multicenter Open-label Trial of Atezolizumab Plus Bevacizumab Versus Transarterial Chemoembolization TACE in Intermediate-stage HepatoCellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The ABC-HCC trial is a Phase IIIb randomised multicenter open-label study designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab versus TACE in patients with intermediate-stage HCC Approximately 434 patients in two arms of treatment will be enrolled
Detailed Description:
The main purpose of this phase IIIb study is to test the efficacy and safety of atezolizumab in combination with bevacizumab compared to TACE in patients with intermediate stage liver cancer
Primary efficacy objective is to assess the efficacy of atezolizumab in combination with bevacizumab compared to TACE in patients with intermediate stage liver cancer
The secondary efficacy objective is to further characterize the responses obtained with the respective therapeutic strategy and to assess the impact of each therapeutic strategy on liver function over time
Furthermore the objective is to evaluate the safety and tolerability of each therapeutic strategy and their respective impact on Quality of Life and to identify prognostic and predictive angiogenic and immune related biomarkers tissue and circulating for study endpoints
This is a Phase IIIb randomised multicenter open-label study Approximately 434 patients suffering from intermediate-stage hepatocellular carcinoma will be enrolled in this trial Patients will be recruited from up to 60 sites in 10 different countries
Primary efficacy objective is to assess the efficacy of atezolizumab in combination with bevacizumab compared to TACE in patients with intermediate stage liver cancer
The secondary efficacy objective is to further characterize the responses obtained with the respective therapeutic strategy and to assess the impact of each therapeutic strategy on liver function over time
Furthermore the objective is to evaluate the safety and tolerability of each therapeutic strategy and their respective impact on Quality of Life and to identify prognostic and predictive angiogenic and immune related biomarkers tissue and circulating for study endpoints
This is a Phase IIIb randomised multicenter open-label study Approximately 434 patients suffering from intermediate-stage hepatocellular carcinoma will be enrolled in this trial Patients will be recruited from up to 60 sites in 10 different countries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004210-35 | EUDRACT_NUMBER | None | None |