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New treatment option for Advanced Hepatocellular Carcinoma
Official title Ligufalimab and Cadonilimab in Advanced Liver Cancers
ClinicalTrials.gov ID: NCT06789848
What this study is testing
What is Ligufalimab?
Ligufalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological confirmation of specific disease -Cohort A (HCC): Patient must have a diagnosis confirmed by histology or clinically by the American...
- Cohort B (BTC, biliary tract cancers): Patients must have histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma...
- 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...
- 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...
You likely can't join if
- 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...
- Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited...
- Interstitial lung disease, including history of interstitial lung disease or non infectious pneumonitis (lymphangitic spread of cancer is not...
See the full eligibility criteria
Who can join
- 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...
- Cohort B (BTC, biliary tract cancers): Patients must have histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers). Patients...
- 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...
- 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...
- 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...
- 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...
- Age ≥ 18 years
- Child-Pugh Score A or B7 (only applicable for Cohort A)
- ECOG Performance score of 0-1
- 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...
- Calculated creatinine clearance (CrCl) ≥ 40 mL/min. CrCl can be calculated using the Cockroft-Gault method.
- Albumin ≥ 2.0 g/dl
- 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...
- 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). 11\. Women of child-bearing potential must have a negative serum...
What rules you out
- 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...
- Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to:
- 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.
- Hypersensitivity to IV contrast; not suitable for pre-medication.
- 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...
- 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...
- Known history of active bacillus tuberculosis.
- people 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...
- 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...
- Known severe hypersensitivity reactions to monoclonal antibodies (≥Grade 3).
- 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...
- Prisoners or people who are involuntarily incarcerated.
- 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
- 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.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has significant dementia or other mental condition that precludes the participant's ability to consent to the study.
- 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.
- Known hypersensitivity to recombinant proteins, or any excipient contained in the study drug formulations.
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.