Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-31 @ 2:11 PM
Study NCT ID:
NCT07115550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-center, Single-arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With Regorafenib in the Treatment of Advanced Second-line or Above Hepatocellular Carcinoma
Sponsor:
Huai'an First People's Hospital
Organization:
Study Overview
Official Title:
A Single-center, Single-arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With Regorafenib in the Treatment of Advanced Second-line or Above Hepatocellular Carcinoma
Status:
NOT_YET_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:
None
Brief Summary:
This study is a prospective, single-center, phase II clinical trial designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706) combined with regorafenib in patients with advanced hepatocellular carcinoma (HCC) who have received at least one prior line of systemic therapy. The trial employs a single-arm design.
Study endpoint
Primary endpoint:
ORR
Secondary endpoint:
DCR, PFS, and OS evaluated based on RECIST v1.1. The incidence and severity of adverse events (AEs)
Study endpoint
Primary endpoint:
ORR
Secondary endpoint:
DCR, PFS, and OS evaluated based on RECIST v1.1. The incidence and severity of adverse events (AEs)
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?: