RecruitingPhase 1

Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer

United States15 participantsStarted 2026-04-01

Plain-language summary

Hepatocellular carcinoma (HCC) is a major cause of cancer-related deaths globally, with Native Hawaiian and Pacific Islander (NHPI) populations experiencing significantly higher mortality rates compared to other groups in Hawaii. This disparity is influenced by factors such as higher prevalence of chronic hepatitis B, non-alcoholic fatty liver disease, limited access to early detection, and delayed diagnoses. NHPI patients are also underrepresented in clinical trials, limiting the relevance of treatment advances for this population. The standard treatment for HCC is surgical resection; however, many NHPI patients present with unresectable disease. Recent advances with immune checkpoint inhibitors (ICIs), such as nivolumab and ipilimumab, have shown promise in treating advanced HCC and improving survival in previously untreatable cases. Additionally, stereotactic body radiotherapy (SBRT) has been shown to enhance survival and local control when combined with systemic therapies like ICIs. However, without surgery, outcomes remain suboptimal, with response rates for ICIs alone at 20-30%, and combination ICI-SBRT treatment showing slightly better results but still a high risk of progression. Despite improvements in HCC treatment, significant gaps remain in managing borderline resectable disease, especially in NHPI patients. This study aims to evaluate the safety and efficacy of combining ICIs and SBRT with curative surgery for patients with borderline resectable HCC, focusing on NHPI populations. The study will also explore the use of biomarkers such as cell-free DNA (cfDNA), CD8+ T-cell infiltration, and serum cytokine markers to guide personalized treatment strategies. Preliminary findings suggest that this multimodal approach may improve outcomes and enable surgical resection for patients previously considered inoperable. This study seeks to address the unmet need for effective treatment strategies in borderline resectable HCC and to improve survival outcomes for underserved NHPI populations.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 system…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of Treatment Regimen

Timeframe: From treatment initiation to surgery completion (up to 12 months)

R0 Resection Rate

Timeframe: From treatment initiation to surgery (up to 12 weeks)

Trial details

NCT IDNCT07075120

SponsorUniversity of Hawaii

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-01

Contact for this trial

Jared D Acoba, MD

8085318521 jacoba@hawaii.edu

View on ClinicalTrials.gov More Hepatocellular Carcinoma (HCC) trials