Ligufalimab and Cadonilimab for Advanced Liver Cancers
This study is testing two drugs, Ligufalimab and Cadonilimab, together to see if they are effective in treating advanced liver cancers, specifically hepatocellular carcinoma (HCC) and biliary tract cancer, that have not responded to previous treatments. Both drugs are checkpoint inhibitors, which are a type of immunotherapy that helps your body's immune system fight cancer. The study aims to measure how many patients experience a reduction in their cancer or a complete disappearance of the cancer (objective response rate). You may be eligible if you are 18 years or older and have a confirmed diagnosis of advanced HCC or biliary tract cancer. The current status of this study is unclear, and it plans to enroll 64 participants.
- Study design
- This is an open-label, non-randomized, Phase II basket clinical trial. It will enroll 64 participants.
- What's involved
- You would receive Ligufalimab intravenously (IV) over 120 minutes, followed by Cadonilimab IV over 60 minutes, on Day 1 every 3 weeks. Treatment will continue until your disease progresses, side effects are too severe, you pass away, or you leave the study for other reasons, for up to 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 24 months, or until disease progression, unacceptable toxicity, or death.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06789848
Ligufalimab and Cadonilimab in Advanced Liver Cancers
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of Texas Southwestern Medical CenterInvestigator-initiated
~64 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:LigufalimabCadonilimab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response rate of combination ligufalimab and cadonilimab
Measured over Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Conditions
NCT06789848
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Texas Southwestern Medical Center
Dallas, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- David Hsieh, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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Eligibility criteria
Inclusion
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. 2. 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.
Measurable disease, as defined as lesions that can accurately be measured in at least one dimension according to RECIST version 1.1 at least 1 cm with contrast enhanced dynamic imaging (magnetic resonance imaging or computed tomography). 3. Refractory to or relapsed after prior anti-PD-1/L1 antibody therapy. May have received anti-PD-1/L1 monotherapy or combination therapy as any line of therapy including in the neoadjuvant or adjuvant setting. Patients who discontinued prior immune checkpoint inhibitor treatment due to a high-grade toxicity (Grade 4) are not eligible. 4. For patients in cohort A who do not have a clinical diagnosis of HCC according to the AASLD criteria, formalin-fixed, paraffin-embedded (FFPE) tumor diagnostic tissue samples must have been obtained within 4 years from the time of consent. Baseline tissue will be requested any time after consent. It is strongly recommended that tissue is obtained from standard-of-care biopsies confirming progression of disease on prior therapy so that the patient has not received any intervening systemic anti-cancer treatment from the time that the baseline tissue was obtained. 5. Prior locoregional therapy is allowed provided the following are met: 1) at least 2 weeks since prior locoregional therapy including surgical resection, chemoembolization, radiotherapy, or ablation; 2) target lesion has increased in size ≥25% since the cessation of locoregional therapy or the target lesion was not treated with locoregional therapy. Patients treated with palliative radiotherapy for symptoms will be eligible as long as the target lesion is not the treated lesion and radiotherapy will be completed at least 2 weeks prior to study drug administration. 6. Age ≥ 18 years 7. Child-Pugh Score A or B7 (only applicable for Cohort A) 8. ECOG Performance score of 0-1 9. Adequate organ and marrow function (without chronic, ongoing growth factor support or transfusion in the last 2 weeks) as defined below:
Platelet count ≥ 50,000/mm3
Hgb ≥ 9 g/dl
Absolute neutrophil ≥ 1,000 cells/mm3
Total bilirubin ≤ 3 mg/ml (This will not apply to subjects with Gilbert's syndrome who have persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis, or patients with hyperbilirubinemia secondary to distal malignant obstruction where endoscopic, surgical, or percutaneous bypass/stenting has been attempted. Such patients may be enrolled based in consultation with the principal investigator)
INR ≤ 2
AST, ALT ≤ 5 times ULN
Calculated creatinine clearance (CrCl) ≥ 40 mL/min. CrCl can be calculated using the Cockroft-Gault method.
Albumin ≥ 2.0 g/dl 10. All men, as well as women of child-bearing potential, defined as not surgically sterilized and between menarche and 1-year post menopause, must agree to use highly effective contraception methods (hormonal or barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation, and for 120 days after the last dose of ligufalimab or cadonilimab.
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Exclusion
Interstitial lung disease, including history of interstitial lung disease or non infectious pneumonitis (lymphangitic spread of cancer is not disqualifying),
Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of study drugs,
Clinically significant cardiovascular disease,
A condition that may obscure the interpretation of toxicity determination or AEs,
History of prior solid-organ transplantation. 6. Hypersensitivity to IV contrast; not suitable for pre-medication. 7. Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study. Participants on chronic systemic corticosteroids will be excluded from the study. 8. Known history of active bacillus tuberculosis. 9. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of study administration. Inhaled or topical steroids and adrenal replacement doses ≤10 mg/day prednisone equivalents are permitted in the absence of autoimmune disease. 10. Patients who discontinued prior immune checkpoint inhibitor treatment due to Grade ≥ 3 or Grade 2 serious toxicity (i.e., pneumonitis, uveitis, neurological symptoms, cardiac toxicity, etc.) immune-related adverse events. 11. Known severe hypersensitivity reactions to monoclonal antibodies (≥Grade 3). 12. Prior malignancy that required systemic treatment within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer. 13. Prisoners or subjects who are involuntarily incarcerated. 14. If a participant has symptomatic or clinically active brain metastases including leptomeningeal disease, they must be excluded if:
Has evidence of progression by neurologic symptoms
Has metastatic brain lesions that require immediate intervention.
Has carcinomatous meningitis, regardless of clinical stability 15. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive hCG laboratory test. 16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 17. Has significant dementia or other mental condition that precludes the participant's ability to consent to the study. 18. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drugs. 19. Known hypersensitivity to recombinant proteins, or any excipient contained in the study drug formulations.
What this trial measures
- Objective Response rate of combination ligufalimab and cadonilimabStudy treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
To determine the best objective response rate assessed by RECIST guidelines (version 1.1) of combination ligufalimab and cadonilimab in patients with advanced hepatobiliary cancers previously exposed to anti-PD-1/L1 antibody treatments.