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).
Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria
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.
Measurable disease according to RECIST 1.1
No prior anti-PD (Programmed death)-1/L1 therapies for any indication
Presence of extrahepatic extension of disease
Prior locoregional therapy to target lesions is not allowed. History of curative locoregional therapy is allowed provided the following are met: 1) previously treated tumor is not viable without evidence of residual disease for at least 12 months, and 2) patient has not received local therapy in the past 12 months.
Known fibrolamellar HCC or combined HCC-cholangiocarcinoma histology
History of hepatic encephalopathy
Parallel
ateganosine
Drugateganosine: 180 mg IV D1, D2, D3 of 21-day cycle
Cadonilimab
Drugcadonilimab: 10 mg/kg IV D5 of 21-day cycle
Incidence of treatment-related delay of surgical resection >28 days from expected surgery date.
Safety is measured as the proportion of participants who experience a treatment-related delay in the planned surgical resection, defined as surgery occurring more than 28 days after the expected surgery date (day 5 of cycle 3 for all treatment arms)
Pathologic response of ateganosine plus cadonilimab
Response will be determined by pathology review of resection specimens and will be based on \<30% residual viable tumor in the tumor bed at the time of surgery.
Radiographic response after ateganosine plus cadonilimab
Radiographic response will be based on changes in only the largest diameter (unidimensional measurement) of the tumor lesions per the RECIST v1.1 criteria.
Survival outcomes after ateganosine plus cadonilimab
Overall survival (measured as time from the first dose of study treatment to death from any cause)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of treatment emergent adverse events (AEs), immune-related AEs, and serious AEs (Grade ≥3 per Common Terminology Criteria for Adverse Events, CTCAE v5.0).
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University of Texas Southwestern Medical Center
Lead sponsor
Maia Biotechnology
Collaborator
National Cancer Institute (NCI)
Collaborator
