NCT06728293 · Indiana University
Effect of the HCC Liver-Link Intervention
What this study is about
This study is a pilot, multi-center randomly assigned controlled trial testing the HCC Liver-Link intervention, a culturally tailored, multi-level program designed to reduce racial disparities in hepatocellular carcinoma (HCC) care.
View original scientific description
This study is a pilot, multi-center randomized controlled trial testing the HCC Liver-Link intervention, a culturally tailored, multi-level program designed to reduce racial disparities in hepatocellular carcinoma (HCC) care. The intervention combines: (1) patient education to improve HCC-related disease and treatment knowledge, (2) social needs and substance use screening with referral to social work and community resources, and (3) facilitated access to subspecialty cancer care through a multidisciplinary HCC tumor board. A total of 40 Black patients with Barcelona Clinic Liver Cancer (BCLC) stage 0, A, or downstaged B disease will be randomized to receive either the HCC Liver-Link intervention or usual care and followed for 6 months or until liver transplant waitlisting. Primary outcomes are time to receipt of curative therapies (liver transplantation or resection) and change in HCC-related knowledge. Findings will inform development of larger interventions to eliminate racial disparities in HCC outcomes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- • Within UCSF criteria: Candidates are eligible or a standardized MELD or PELD exception if, before completing locoregional therapy, they have lesions that meet one of the following criteria:
- One Class 5 lesion greater than 5 cm and less than or equal to 8 cm
- two or three Class 5 lesions that meeting all of the following
- At least one lesion greater than 3cm
- Each lesion less than or equal to 5 cm, and
- A total diameter of all lesions less than or equal to 8cm
- Four or five Class 5 lesions each less than 3 cm, and a total diameter of all lesions less than or equal to 8 cm.
- Between 18-75 years old
- Have no more than two visits with an HCC-related provider
- Able to read, write, and speak English
- Any 1 of the following:
- Self-report as Black race (can be multiple races as long as 1 is Black)
- Self-report as insured by Medicaid (+/- Medicare)
- SVI (Social vulnerability index) \>= .75
Exclusion criteria
- Lacks capacity to provide informed consent, including those with stage 2 HE or higher at the time of consent.
- Age over 75
- Last transthoracic echocardiogram with EF\<40% (OK if no prior echo)
- BMI over 50
- Patients who, in the investigator's judgment, are unlikely to ever be eligible for liver transplantation or resection at the time of enrollment, with reason documented
- Prior history of any solid organ transplant
- Non-skin cancer malignancies other than hepatocellular carcinoma in past 2 years unless approved by PI (i.e. cervical cancer, early prostate cancer)
- Patients who have undergone resection or waitlisted
- Patients near completion of transplant evaluation, PI to determine utility of intervention.
Where
- Indianapolis, Indiana
- Baltimore, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations