NCT07446257

THIO and Cadonilimab in Resectable Hepatocellular Carcinoma

A Phase Ib Open-label, Randomized Trial Evaluating Neoadjuvant Ateganosine and Cadonilimab in Resectable Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Resectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	ateganosine	ateganosine: 180 mg IV D1, D2, D3 of 21-day cycle
DRUG	Cadonilimab	cadonilimab: 10 mg/kg IV D5 of 21-day cycle

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-05-01
• Completion: 2031-05-01
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study