Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 4:38 AM
Study NCT ID:
NCT04954794
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2021-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TACE Combined with Sintilimab Plus Bevacizumab Biosimilar in Patients with Advanced Hepatocellular Carcinoma (TASK-02)
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined with Sintilimab Plus Bevacizumab Biosimilar in Patients with Advanced Hepatocellular Carcinoma (TASK-02)
Status:
COMPLETED
Status Verified Date:
2024-10
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 objective of this study is to evaluate the efficacy and safety of TACE combined with Sintilimab plus bevacizumab biosimilar in patients with advanced hepatocellular carcinoma as first-line therapy.
Detailed Description:
Transarterial chemoembolization (TACE) is commonly used for the treatment of advanced hepatocellular carcinoma. Early randomized trials suggested that TACE can be accepted as the standard treatment for advanced-stage disease. However, the outcome of patients treated with TACE in real-life cohorts is still very poor.
Recent studies have also supported a safe combination of immune checkpoint inhibition with TACE. And the combination of sintilimab plus bevacizumab biosimilar showed significantly improved survival in advanced HCC. Therefore, the objective of this study is to evaluate the efficacy and safety of TACE combined with anti-PD-1 antibody in patients in advanced hepatocellular carcinoma.
Recent studies have also supported a safe combination of immune checkpoint inhibition with TACE. And the combination of sintilimab plus bevacizumab biosimilar showed significantly improved survival in advanced HCC. Therefore, the objective of this study is to evaluate the efficacy and safety of TACE combined with anti-PD-1 antibody in patients in advanced hepatocellular carcinoma.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: