Actively Recruiting
Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer
Led by University of Hawaii · Updated on 2026-04-30
15
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed hepatocellular cancer
- Locally advanced or borderline resectable hepatocellular carcinoma defined by: solitary tumor larger than 5 cm; or unilobar multifocal disease with more than 3 tumors or one tumor larger than 3 cm; or bilobar disease with adequate future liver remnant and technically resectable; or high-risk disease features such as tumor larger than 3 cm with macrovascular invasion or AFP greater than 400
- No spread outside the liver, no lymph node disease, no involvement of both left and right portal vein branches, no hepatic vein or inferior vena cava involvement; unilateral hepatic vein involvement allowed
- Measurable disease as determined by RECIST 1.1 criteria
- Age 18 years or older at consent
- ECOG performance status of 1 or less
- Adequate organ and marrow function including hemoglobin 9 g/dL or higher, absolute neutrophil count 1000/μL or higher, platelet count 90,000/μL or higher, total bilirubin less than 2.0 mg/dL, AST and ALT less than or equal to 5 times the upper limit of normal, albumin 2.8 g/dL or higher, INR less than or equal to 2 times the upper limit of normal, and creatinine clearance 40 mL/minute or higher without recent transfusions or growth factor support within 14 days of first dose
You will not qualify if you...
- Prior systemic therapy for hepatocellular carcinoma
- Radiation treatment to more than 30% of bone marrow or wide radiation field within 28 days before first study drug dose
- Ascites requiring ongoing paracentesis within 6 weeks before starting treatment
- Active or recent gastrointestinal variceal bleeding or ulcers within 60 days before registration
- Hepatic encephalopathy within 12 months before trial registration
- Uncontrolled hypertension with diastolic blood pressure over 90 mmHg or systolic over 140 mmHg
- Previous external beam radiation therapy to the liver or prior yttrium-90 radioembolization
- Hepatitis B viral load over 100 IU/mL, ongoing corticosteroid therapy over 10 mg prednisone daily, or active autoimmune disease requiring systemic therapy in past 2 years
- Tumor extension into stomach, duodenum, small or large bowel
- Active or untreated central nervous system or leptomeningeal metastases
- History of other primary malignancy except if treated with curative intent and no active disease for 5 or more years, or adequately treated non-melanoma skin cancer, lentigo maligna, or carcinoma in situ without evidence of disease
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Active infection including tuberculosis or HIV infection
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Actively Recruiting
2
University of Hawai'i Cancer Center
Honolulu, Hawaii, United States, 96813
Not Yet Recruiting
Research Team
J
Jared D Acoba, MD
CONTACT
T
Tomomi Otaki
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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