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Effect of the HCC Liver-Link Intervention

Effect of the HCC Liver-Link Intervention

Recruiting
18-75 years
All
Phase N/A

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Overview

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

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.

Study details
    HCC
    Racial Disparities

NCT06728293

Indiana University

16 October 2025

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