Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:31 AM
Study NCT ID:
NCT07446257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THIO and Cadonilimab in Resectable Hepatocellular Carcinoma
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
A Phase Ib Open-label, Randomized Trial Evaluating Neoadjuvant Ateganosine and Cadonilimab in Resectable Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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 goal of this clinical study is to find out if cadonilimab or ateganosine plus cadonilimab is effective and safe in treating resectable hepatocellular carcinoma (HCC).
Detailed Description:
In this study, ateganosine (also know as THIO, 6-thio-dG, 6-thio-2'-deoxyguanosine) and cadonilimab are given via intravenous infusion. The participant will be randomly assigned to receive cadonilimab alone, ateganosine alone, or ateganosine and cadonilimab.
For this study, a cycle is defined as 21 calendar days during which drugs are administered.
If the participant is randomized to the cadonilimab alone arm, infusions will be given on the first day of every 21-day cycle. The participant will receive 2 doses of cadonilimab and then be evaluated for surgery.
If the participant is randomized to be treated with ateganosine alone, infusions of ateganosine will be given on days 1 to 3 of every 21-day cycle for 3 cycles and then the participant will be evaluated for surgery.
If the participant is randomized to be treated with ateganosine and cadonilimab, infusions of ateganosine will be given on days 1 to 3 of every 21-day cycle for 3 cycles. Infusions of cadonilimab will be given on day 5 of every 21-day cycle for 2 cycles. After receiving 3 cycles of ateganosine and 2 cycles of cadonilimab, the participant will be evaluated for surgery.
For this study, a cycle is defined as 21 calendar days during which drugs are administered.
If the participant is randomized to the cadonilimab alone arm, infusions will be given on the first day of every 21-day cycle. The participant will receive 2 doses of cadonilimab and then be evaluated for surgery.
If the participant is randomized to be treated with ateganosine alone, infusions of ateganosine will be given on days 1 to 3 of every 21-day cycle for 3 cycles and then the participant will be evaluated for surgery.
If the participant is randomized to be treated with ateganosine and cadonilimab, infusions of ateganosine will be given on days 1 to 3 of every 21-day cycle for 3 cycles. Infusions of cadonilimab will be given on day 5 of every 21-day cycle for 2 cycles. After receiving 3 cycles of ateganosine and 2 cycles of cadonilimab, the participant will be evaluated for surgery.
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?:
None
Is an FDA AA801 Violation?: