Actively Recruiting
Ligufalimab and Cadonilimab in Advanced Liver Cancers
Led by University of Texas Southwestern Medical Center · Updated on 2026-02-27
64
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
A
Akesobio
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ligufalimab and Cadonilimab in Advanced Liver Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or clinical confirmation of hepatocellular carcinoma (HCC) or biliary tract cancer (BTC) as specified for cohorts A and B
- Locally advanced or metastatic disease not suitable for surgery or locoregional therapy, or progression after such treatments
- Measurable disease with lesions at least 1 cm by contrast-enhanced imaging
- Disease refractory to or relapsed after prior anti-PD-1/L1 antibody therapy, excluding those who stopped due to grade 4 toxicity
- For certain HCC patients, tumor tissue samples obtained within 4 years prior to consent
- At least 2 weeks elapsed since prior locoregional therapy
- Age 18 years or older
- Child-Pugh Score A or B7 for cohort A
- ECOG performance status 0-1
- Adequate organ and marrow function as defined by specific laboratory values
- Agreement to use effective contraception before, during, and after study participation for those of child-bearing potential
- Negative pregnancy test for women of child-bearing potential
- Eligibility of patients with non-viral or viral hepatitis related HCC under specified conditions
- Ability to understand and sign informed consent
- Willingness and ability to comply with study requirements
- Prior COVID-19 vaccination allowed
You will not qualify if you...
- Prior liver transplant
- Known HIV positive status
- Use of live vaccines within 28 days before study drug
- Major surgery or trauma within 28 days before study drug, excluding tumor biopsy or central venous access placement
- Medical conditions making study drug administration hazardous, including interstitial lung disease, recent serious infections, significant heart disease, or prior organ transplantation
- Hypersensitivity to IV contrast media without possibility of pre-medication
- Active autoimmune diseases requiring systemic treatment in past 2 years, except certain exceptions
- History of active tuberculosis
- Use of systemic corticosteroids or immunosuppressants within 14 days before study drug, with some exceptions
- Discontinuation of prior immune checkpoint inhibitors due to serious or specific toxicities
- Severe hypersensitivity to monoclonal antibodies
- Recent malignancies requiring systemic treatment within 2 years, except certain cured cancers
- Prisoners or involuntarily incarcerated subjects
- Symptomatic or active brain metastases requiring immediate intervention or carcinomatous meningitis
- Pregnant or nursing women
- Psychiatric or substance abuse disorders interfering with trial compliance
- Significant dementia or mental conditions preventing informed consent
- Use of other investigational drugs within specified time before study drug
- Known hypersensitivity to recombinant proteins or study drug components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
C
Carrie Manwaring
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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