New drug combo aims to shrink liver tumors before surgery
NCT ID NCT07446257
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times
Summary
This study tests whether giving two drugs (ateganosine and cadonilimab) before surgery can safely shrink liver tumors in people with resectable hepatocellular carcinoma. About 60 participants will receive either one or both drugs before their operation. The main goal is to see if the treatment delays surgery, while also checking how well the tumors respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of HCC confirmed by histology or according to the American Association for the Study of Liver Disease (AASLD) criteria a. Availability of tumor tissue samples prior to the first day of study treatment is required for all patients. 2. 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. 3. Measurable disease according to RECIST 1.1 4. No prior anti-PD (Programmed death)-1/L1 therapies for any indication 5. Age ≥18 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 7. Child Pugh A 8. Adequate organ and marrow function as defined below: 1. ANC (absolute neutrophil count) ≥ 1.5 x 109/L (does not apply to patients with benign ethnic neutropenia) 2. Platelets ≥ 75 x 109/L without transfusion 3. Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks of screening 4. ALT (Alanine Aminotransferase) ≤ 3 2 x ULN (Upper Limit of Normal) 5. Bilirubin ≤ 3 x ULN 6. Creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault formula using actual body weight 9. All etiologies of chronic liver disease including but not limited to Hepatis C Virus (HCV) or Hepatis B Virus (HBV) infection. HCV and HBV infection status does not preclude eligibility as long as patients meet all other eligibility criteria but must be known prior to starting treatment. Patients with HBV must be on anti-viral therapy prior to the first day of investigational drug treatment. Patients with HCV may include active or resolved infection. 10. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months following the last dose of ateganosine or 4 months following the last dose of cadonilimab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * 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. Ability to understand and the willingness to sign a written informed consent. 12. Willing and able to comply with the requirements and restrictions in this protocol. Exclusion Criteria: 1. Presence of extrahepatic extension of disease 2. 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. 3. Known fibrolamellar HCC or combined HCC-cholangiocarcinoma histology 4. History of hepatic encephalopathy 5. Severe ascites requiring paracentesis in the past 3 months 6. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study 7. Prior significant bleeding event in the past 3 months that may pose a surgical risk 8. 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) 9. Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to: 1. Autoimmune interstitial lung disease (lymphangitic spread of cancer is not disqualifying or stable/chronic lung disease that is not likely to be autoimmune in nature and progressive), 2. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of study drugs, 3. Clinically significant cardiovascular disease, 4. A condition that may obscure the interpretation of toxicity determination or AEs, 5. History of prior bone marrow and/or solid-organ transplantation 10. Hypersensitivity to IV contrast; not suitable for pre-medication 11. Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past year (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), with the following exceptions: 1. Autoimmune diseases with only dermatologic involvement such as eczema, vitiligo, lichen chronicus, or resolved childhood asthma/atopy which involves less than 10% of the body surface area and symptoms are well controlled on topical treatments without recent exacerbations requiring other therapies 2. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) is not considered a form of systemic treatment 3. Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study 12. 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. 13. 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. Patients with a cancer history with a low risk of recurrence or progression may be enrolled as determined by the principal investigator. 14. Prisoners or subjects who are involuntarily incarcerated 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 (Human chorionic gonadotropin) laboratory test 16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial 17. Evidence of bleeding diathesis or significant coagulopathy 18. Current use of full dose anticoagulant use which cannot be temporarily discontinued for surgery 19. Receipt of live vaccinations within 30 days of first treatment day
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Texas Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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