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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: Recruiting Phase 1 study, sponsored by University of Hawaii.
NCT07075120 is a Phase 1 study that is actively recruiting participants, run by University of Hawaii. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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)
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 |
What NCT07075120 shows while recruiting
NCT07075120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Stereotactic Body Radiotherapy (SBRT) is the first listed.
NCT07075120 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07075120's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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