Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04723004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-14
First Post:
2021-01-21
Brief Title:
Evaluate the Safety and Efficacy of Toripalimab Combined With Bevacizumab Versus Sorafenib Therapy for HCC
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
A Randomized Open-label Multi-center Phase III Clinical Study to Evaluate the Safety and Efficacy of Toripalimab JS001 Combined With Bevacizumab Versus Sorafenib as First-line Therapy for Advanced Hepatocellular Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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:
This is a prospective randomized open-label parallel-group active controlled multi-center phase III registration clinical study to observe compare and evaluate the efficacy and safety of Toripalimab hereafter referred to as JS001 combined with Bevacizumab versus Sorafenib as the first-line therapy for advanced HCC This study will enroll the patients with locally advanced or metastatic hepatocellular carcinoma who could not be radically cured and not receive any prior systemic therapy The study will use PFS and OS as the co-primary endpoints with approximately 280 patients planned to be enrolled
Detailed Description:
None
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