Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 11:42 PM
Study NCT ID:
NCT07100392
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab: A Randomized, Phase 2 Study.
Status:
RECRUITING
Status Verified Date:
2025-08
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:
LEAF-02
Brief Summary:
To evaluate the efficacy and safety of Tauroursodeoxycholic Acid (TUDCA) plus Camrelizumab and Regorafenib for patients with advanced hepatocellular carcinoma (HCC) who have progressed on prior systemic treatment with Anti-PD1/PD-L1 plus bevacizumab combination.
Detailed Description:
This is a phase 2, open-label, randomized, three-arm study designed to evaluate the efficacy and safety of Regorafenib in Combination With Either Camrelizumab monotherapy or Camrelizumab plus Tauroursodeoxycholic Acid (TUDCA) in participants with advanced hepatocellular carcinoma (HCC) who have progressed on prior systemic treatment with Anti-PD1/PD-L1 plus bevacizumab combination.
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?:
None
Is an FDA AA801 Violation?: