THIO and Cadonilimab in Resectable Hepatocellular Carcinoma

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ateganosine
  • Cadonilimab

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Texas Southwestern Medical Center

Lead sponsor

Maia Biotechnology

Collaborator

National Cancer Institute (NCI)

Collaborator