Not Yet RecruitingEarly Phase 1

THIO and Cadonilimab in Resectable Hepatocellular Carcinoma

United States60 participantsStarted 2026-05-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Age ≥18
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
✓. Child Pugh A
✓. Adequate organ and marrow function as defined below:

Exclusion criteria

✕. 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
✕. Severe ascites requiring paracentesis in the past 3 months
✕. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
✕. Prior significant bleeding event in the past 3 months that may pose a surgical risk
✕. History of trauma or major surgery within 28 days prior to the first dose of study drug administration. (Tumor biopsy or placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure)

What they're measuring

Incidence of treatment-related delay of surgical resection >28 days from expected surgery date.

Timeframe: 28 days after the expected surgery date (day 5 of cycle 3 for all treatment arms)

Trial details

NCT IDNCT07446257

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-05-01

Contact for this trial

Carrie Manwaring

214-648-7097 carrie.manwaring@utsouthwestern.edu

View on ClinicalTrials.gov More Resectable Hepatocellular Carcinoma trials