Ligufalimab and Cadonilimab in Advanced Liver Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The goal of this clinical trial is to find out if the combination of Ligufalimab and Cadonilimab are effective in treating advanced hepatobiliary cancers that have failed prior therapy.
Eligibility criteria
Qualifiers
Histological confirmation of specific disease -Cohort A (HCC): Patient must have a diagnosis confirmed by histology or clinically by the American Association for the Study of Liver Diseases (AASLD) criteria in patients with cirrhosis. Known fibrolamellar HCC will be excluded.
Cohort B (BTC, biliary tract cancers): Patients must have histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers). Patients with combined HCC-cholangiocarcinoma may be enrolled in Cohort B.
Locally advanced or metastatic disease
Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional therapies.
Disqualifiers
Prior liver transplant.
Known human immunodeficiency virus (HIV) positive (testing not required).
Use of any live vaccines against infectious diseases within 28 days of first dose of study drug administration.
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).
Trial design
Treatments tested in this trial
- Ligufalimab
- Cadonilimab
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Texas Southwestern Medical Center
Lead sponsor
Akesobio
Collaborator
Josephine Hughes Sterling Foundation
Collaborator
Source ClinicalTrials.gov