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Ipilimumab and Nivolumab with SBRT for Locally Advanced Liver Cancer

This study is testing a new treatment approach for locally advanced hepatocellular carcinoma (HCC), a type of liver cancer. It combines two immunotherapy drugs, Ipilimumab and Nivolumab, with Stereotactic Body Radiotherapy (SBRT). Immunotherapy helps your body's immune system fight cancer, while SBRT is a focused radiation treatment. The study aims to see if this combination is feasible and how well it helps shrink tumors, potentially allowing for surgery. You might be eligible if you have confirmed HCC that is considered locally advanced or borderline resectable, and are at least 18 years old. The study is currently recruiting about 15 participants.

Study design
This study is an interventional trial, meaning participants will receive a specific treatment. It plans to enroll 15 participants.
What's involved
The study measures feasibility of the treatment regimen from initiation to surgery completion (up to 12 months) and R0 Resection Rate (up to 12 weeks).
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes up to 12 months after treatment initiation for feasibility and up to 12 weeks for the R0 Resection Rate.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07075120

Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Hawaii
~15 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Ipilimumab and NivolumabStereotactic Body Radiotherapy (SBRT)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Treatment Regimen
Measured over From treatment initiation to surgery completion (up to 12 months)
+1 more outcome measured

Conditions

Hepatocellular Carcinoma (HCC)

Explore related trials

Hepatocellular CarcinomaAlpha-Fetoprotein

Where it's being run

2 sites across 1 states
Hawaii2

Study leadership

  • Jared D Acoba, MD · PRINCIPAL_INVESTIGATOR · University of Hawaii

Who to contact

Jared D Acoba, MD
[email protected]
8085318521
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Feasibility of Treatment RegimenFrom treatment initiation to surgery completion (up to 12 months)

    Feasibility will be defined as fewer than 5 failures of resection due to treatment-related factors (e.g., toxicity, delay in treatment). (Co-primary endpoint; this outcome assesses the tolerability and logistical feasibility of the neoadjuvant treatment strategy.) Unit of Measure: Number of failures (count)

  • R0 Resection RateFrom treatment initiation to surgery (up to 12 weeks)

    The proportion of patients achieving R0 surgical resection, defined as complete resection with negative margins. (Co-primary endpoint; this outcome reflects the treatment's impact on surgical resectability.) Unit of Measure: Percentage of participants