Honolulu, HINCT07075120Now EnrollingIRB Ready

Hepatocellular Carcinoma (HCC) Clinical Trial in Honolulu, HI

Access cutting-edge hepatocellular carcinoma (hcc) treatment through this clinical trial at a research site in Honolulu. Study-provided care at no cost to qualified participants.

Sponsored by University of Hawaii

Quick Self-Assessment

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Expert Care in Honolulu

Access hepatocellular carcinoma (hcc) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hepatocellular carcinoma (hcc) treatment provided free

Apply for This Honolulu Location

Check if you qualify for this hepatocellular carcinoma (hcc) clinical trial in Honolulu, HI

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Honolulu

    Convenient for HI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Honolulu site if eligible
  4. 4Begin participation

About This Hepatocellular Carcinoma (HCC) Study in Honolulu

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.

Sponsor: University of Hawaii

Who Can Participate

Exclusion 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
Prior systemic therapy for hepatocellular carcinoma
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s).
Ascites that requires ongoing paracentesis, within 6 weeks prior to the first scheduled dose, to control symptoms.
Active or prior documented GI variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 60 days prior to registration; adequate endoscopic therapy according to institutional standards is required for patients with history of esophageal variceal bleeding or assessed as high risk for esophageal variceal by the treating investigator.
Hepatic encephalopathy within 12 months of trial registration
Patient currently exhibits symptomatic or uncontrolled hypertension defined as diastolic blood pressure \>90 mmHg or systolic blood pressure \>140 mmHg.
Prior external beam radiation therapy to the liver, prior yttrium-90 radioembolization
HBV viral load \>100 IU/mL, ongoing corticosteroid therapy \>10 mg prednisone daily, and active autoimmune disease requiring systemic therapy in the past 2 years.
Direct tumor extension into stomach, duodenum, small or large bowel
Active or untreated central nervous system (CNS) and leptomeningeal metastases
History of another primary malignancy except for:
Malignancy treated with curative intentand with no known active disease ≥ 5years before the first dose of study drug(s) and of low potential risk for recurrence
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), or human immunodeficiency virus (positive human HIV 1/2 antibodies).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Honolulu?

Yes, this clinical trial (NCT07075120) has an active research site in Honolulu, HI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hepatocellular Carcinoma (HCC) Treatment Options in Honolulu, HI

If you're searching for hepatocellular carcinoma (hcc) treatment options in Honolulu, HI, this clinical trial (NCT07075120) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Honolulu research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hepatocellular carcinoma (hcc) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hepatocellular carcinoma (hcc) clinical trials near you to find additional studies recruiting in your area.

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