New combo therapy aims to make inoperable liver cancer removable
NCT ID NCT07075120
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests a combination of two immunotherapy drugs (ipilimumab and nivolumab) and focused radiation before surgery in 15 people with advanced liver cancer that is borderline removable. The goal is to see if this approach is safe and can shrink tumors enough to allow complete surgical removal. The study focuses on Native Hawaiian and Pacific Islander patients, who are often underrepresented in research and have higher death rates from this cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ipilimumab and Nivolumab (immunotherapy drugs) plus stereotactic body radiotherapy (focused radiation)
- What this could lead to
- If successful, this approach could make surgery possible for more patients with advanced liver cancer and improve survival, especially for underserved populations.
- What could go wrong
- This is a very early, small pilot study with only 15 participants. The combination of treatments may cause serious side effects, and it is unknown if it will work better than standard care.
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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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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.
Main Criteria for Inclusion/Exclusion * Inclusion Criteria: * Histologically or cytologically confirmed hepatocellular cancer * Locally advanced/borderline resectable HCC as defined by: * Solitary tumor \>5 cm, OR * Unilobar multifocal disease either with \>3 tumors or one tumor \>3 cm, OR * Bilobar disease with adequate future liver remnant, still technically resectable, OR * High risk disease features (tumor \>3 cm with macrovascular invasion or tumor \>3 cm with AFP\>400). * No extrahepatic spread, no nodal disease, no bilateral left and right branch portal vein involvement, no hepatic vein / IVC involvement. Unilateral hepatic vein involvement is not exclusionary. * Measurable disease per RECIST 1.1 as determined by the investigator * Age ≥ 18 years old on the day of consent * ECOG performance status ≤1 (Appendix XX) * Adequate organ and marrow function, as defined below. Criteria "a," "b," "c," and "f" cannot be met with transfusions, infusions, or growth factor support administered within 14 days of starting the first dose. * Hemoglobin ≥9 g/dL * Absolute neutrophil count ≥1000/μL * Platelet count ≥90,000/μL * Total bilirubin (TBL) \<2.0 mg/dL * ASTandALT≤5×ULN * Albumin≥2.8g/dL * International normalized ratio(INR)≤2xULN * Calculated creatinine clearance ≥ 40 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance * Exclusion Criteria: * Prior systemic therapy for hepatocellular carcinoma * Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s). * Ascites that requires ongoing paracentesis, within 6 weeks prior to the first scheduled dose, to control symptoms. * Active or prior documented GI variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 60 days prior to registration; adequate endoscopic therapy according to institutional standards is required for patients with history of esophageal variceal bleeding or assessed as high risk for esophageal variceal by the treating investigator. * Hepatic encephalopathy within 12 months of trial registration * Patient currently exhibits symptomatic or uncontrolled hypertension defined as diastolic blood pressure \>90 mmHg or systolic blood pressure \>140 mmHg. * Prior external beam radiation therapy to the liver, prior yttrium-90 radioembolization * HBV viral load \>100 IU/mL, ongoing corticosteroid therapy \>10 mg prednisone daily, and active autoimmune disease requiring systemic therapy in the past 2 years. * Direct tumor extension into stomach, duodenum, small or large bowel * Active or untreated central nervous system (CNS) and leptomeningeal metastases * History of another primary malignancy except for: * Malignancy treated with curative intentand with no known active disease ≥ 5years before the first dose of study drug(s) and of low potential risk for recurrence * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * Adequately treated carcinoma in situ without evidence of disease * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. * Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), or human immunodeficiency virus (positive human HIV 1/2 antibodies).
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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
2 sites. 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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The Queen's Medical Center
RECRUITINGHonolulu, Hawaii, 96813, United States
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University of Hawai'i Cancer Center
NOT_YET_RECRUITINGHonolulu, Hawaii, 96813, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Triple drug combo targets advanced liver cancer in new trial
- Can two immunotherapy drugs make liver tumors more vulnerable to surgery?
- Saline barrier lets heat target liver tumors near the diaphragm
- Can a new PET tracer spot liver cancer more clearly?
- Can a smart drug starve liver tumors without harming healthy tissue?