A Phase Ib Open-label, Randomized Trial Evaluating Neoadjuvant Ateganosine and Cadonilimab in Resectable Hepatocellular Carcinoma
University of Texas Southwestern Medical Center
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).
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria a. Availability of tumor tissue samples prior to the first day of study treatment is required for all patients. 2. HCC that is amenable to R0 resection with curative intent as determined by treating surgical/medical oncologists in consultation with the principal investigator. Subject must be a suitable candidate for surgery based on evaluations by the treating surgeon/oncologist. 3. Measurable disease according to RECIST 1.1 4. No prior an…
Interventions
- Drugateganosine
ateganosine: 180 mg IV D1, D2, D3 of 21-day cycle
- DrugCadonilimab
cadonilimab: 10 mg/kg IV D5 of 21-day cycle
Location
- University of Texas Southwestern Medical CenterDallas, Texas