NCT06728293 Effect of the HCC Liver-Link Intervention
| NCT ID | NCT06728293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | HCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-06-10 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06728293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying HCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06728293 currently recruiting?
Yes, NCT06728293 is actively recruiting participants. Contact the research team at samussel@iu.edu for enrollment information.
Where is the NCT06728293 trial being conducted?
This trial is being conducted at Indianapolis, United States, Baltimore, United States.
Who is sponsoring the NCT06728293 clinical trial?
NCT06728293 is sponsored by Indiana University. The trial plans to enroll 40 participants.