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NCT07075120 · ClinicalTrials.gov registry record · Phase 1
Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer
A Phase 1 study, sponsored by University of Hawaii.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT07075120 is a Phase 1 study that is actively recruiting participants, run by University of Hawaii. The registered enrollment target is 15 participants.
The verdict
NCT07075120, a Phase 1 study, is actively recruiting participants, sponsored by University of Hawaii.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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
Interventions
- RADIATION Stereotactic Body Radiotherapy (SBRT)
- DRUG Ipilimumab and Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07075120
The ClinicalTrials.gov registry entry for NCT07075120 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Hawaii, which has 77 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Stereotactic Body Radiotherapy (SBRT) is the first listed.
NCT07075120 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07075120 about?
NCT07075120 is a clinical study titled "Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer". 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 c...
What is the current status of trial NCT07075120?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2026-04-01. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT07075120?
The interventions under investigation include: Stereotactic Body Radiotherapy (SBRT) (RADIATION), Ipilimumab and Nivolumab (DRUG).
Who is sponsoring clinical trial NCT07075120?
This trial is sponsored by University of Hawaii, which has 77 total clinical trials registered on ClinicalTrials.gov.
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