Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05537402
Status:
TERMINATED
Last Update Posted:
2025-09-24
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LOcoregional vs Systemic Therapy in Patients With BCLC Stage B HCC
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Phase II Multi-center Randomized, Open-label, Trial of Atezolizumab and Bevacizumab vs Locoregional Therapy (Transarterial Chemoembozliation or Radioembolization) as First-line Therapy in Patients With Large Intermediate-stage Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The decision was made to close the study to enrollment due to poor overall accrual and the inability to meet the 31% overall enrollment goal.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOST-B
Brief Summary:
The purpose of this research study is to compare the effectiveness and safety of two standard of care treatments in people who have been diagnosed with hepatocellular carcinoma (HCC).This research study is being done to compare atezolizumab/bevacizumab to locoregional therapy with either transarterial chemoembolization (TACE) or transarterial radioembolization (TARE).
Detailed Description:
To evaluate the efficacy and safety of atezolizumab and bevacizumab compared to locoregional therapy (TACE or TARE) in patients with intermediate-stage HCC. The primary outcome is progression-free survival, which will be compared between two arms using stratified log-rank tests, adjusting the effect of stratification variables between two study arms. Cox regression analysis will be done to see if there are significant differences in PFS, controlling for the effects of confounding variables between the two study arms.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: