HCC Liver-Link program to reduce racial gaps in liver cancer care
Effect of the HCC Liver-Link Intervention
This pilot will test whether the HCC Liver-Link program helps Black patients with early-stage HCC get faster curative treatment (transplant or resection) and better knowledge about their disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT06728293 on ClinicalTrials.gov |
What this trial studies
This is a multi-center, randomized pilot comparing the HCC Liver-Link intervention to usual care in 40 Black patients with BCLC stage 0, A, or downstaged B HCC. The intervention combines culturally tailored patient education, social needs and substance use screening with referrals, and facilitated access to subspecialty care through a multidisciplinary HCC tumor board. Participants are randomized and followed for six months or until liver transplant waitlisting. Primary outcomes are time to receipt of curative therapies and change in HCC-related knowledge to inform larger future interventions.
Who should consider this trial
Good fit: Black patients aged 18–75 with early-stage (BCLC 0, A, or downstaged B) HCC who meet UCSF lesion criteria, have had no more than two prior HCC-provider visits, can read/write/speak English, and meet at least one listed social vulnerability or insurance/unmarried criterion.
Not a fit: Patients with more advanced HCC beyond the listed stages, those already extensively engaged in HCC care or already waitlisted for transplant, non-English speakers, or those lacking decision-making capacity are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the program could shorten time to liver transplantation or resection and improve patient knowledge, helping narrow racial disparities in HCC outcomes.
How similar studies have performed: Navigation, culturally tailored education, and social-needs screening have improved access and engagement in other cancer settings, but this specific bundled approach for reducing racial disparities in HCC care is relatively novel and not yet widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Unmarried 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 this trial is running
Indianapolis, Indiana and 1 other locations
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Savannah Yarnelle
- Email: samussel@iu.edu
- Phone: (317) 278-6424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.