NCT07075120

Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer

Not yet recruiting Phase 1 Last updated 31 March 2026

What this trial tests

Phase 1 trial testing Ipilimumab and Nivolumab in Hepatocellular Carcinoma (HCC) in 15 participants. Not yet recruiting.

Timeline

1 April 2026

Primary endpoint
1 August 2027

31 December 2027

Quick facts

Lead sponsor	University of Hawaii
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 April 2026
Primary completion	1 August 2027
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Ipilimumab and Nivolumab — full drug profile →
• Stereotactic Body Radiotherapy (SBRT) — full drug profile →

Conditions studied

• Hepatocellular Carcinoma (HCC) — all drugs for Hepatocellular Carcinoma (HCC) →

Sponsor

University of Hawaii

Who can join

18 and older, any sex, with Hepatocellular Carcinoma (HCC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.