Liver Link Intervention for Liver Cancer

Recruiting at 1 trial location

Overseen By Regina Weber

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Age over 75, BMI over 50, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Liver Link, designed to improve care for Black patients with liver cancer, specifically hepatocellular carcinoma (HCC). The program aims to enhance patient education, address social needs and substance use, and ensure better access to cancer specialists. Researchers aim to determine if this approach can speed up access to treatments like liver transplants. Suitable candidates for this trial are Black individuals with early-stage liver cancer who have had limited visits with liver cancer doctors and face certain social or economic challenges. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies and potentially improve access to life-saving treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for guidance.

What prior data suggests that the Liver Link intervention is safe?

Research has shown that the Liver Link program educates patients and connects them to necessary resources and specialists. While specific safety data for the Liver Link program is not available, its non-drug-based nature suggests it is likely safe. The program emphasizes education and support, which typically do not carry the safety concerns associated with new medications. Participants in this study are expected to gain improved knowledge and access to care, positively impacting their treatment journey. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Liver Link intervention because it offers a comprehensive approach to managing liver cancer, focusing not just on the medical aspects, but also on the patient's overall well-being. Unlike standard treatments, which primarily center on medical procedures and medications, Liver Link includes support groups, social work referrals, and milestone assessments to address social needs and substance use. This holistic approach aims to enhance patients' quality of life and understanding of their disease, potentially leading to better health outcomes and patient satisfaction.

What evidence suggests that the Liver Link intervention could be effective for reducing racial disparities in liver cancer care?

Research has shown that the HCC Liver-Link program, available to participants in this trial, might enhance care and treatment outcomes for individuals with liver cancer. This program seeks to educate patients about liver cancer and connect them with necessary care. Studies have found that patients adhering to treatment guidelines often experience longer survival. The Liver-Link program aims to expedite access to beneficial treatments by improving patients' understanding and access to healthcare services. While direct evidence of the program's success is not yet available, it aims to reduce healthcare disparities and improve patient outcomes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Black patients with early-stage liver cancer (Hepatocellular Carcinoma) who have not yet received curative therapies. It aims to address racial disparities in healthcare by helping patients navigate the healthcare system and improve their knowledge about their disease and treatment options.

Inclusion Criteria

I am covered by Medicare.

Ability to provide written informed consent and HIPAA authorization

Self-reported Black race

Exclusion Criteria

EF<40%

I have had cancer other than liver cancer.

I am not considered a candidate for liver surgery or transplant according to my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants proceed through the Liver-Link component intervention, including assessments for disease knowledge, quality of life, substance use, and social needs. They attend support groups and complete milestone checks.

6 months

3 milestone checks, 2 HCC-related visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of exit surveys and knowledge assessments.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liver Link

Trial Overview

The 'Liver Link' intervention is being tested to see if it can reduce the time it takes for Black patients with liver cancer to receive curative treatments. It includes education, screening for social needs and substance use, and coordination with a tumor board to connect patients to specialized care.

How Is the Trial Designed?

Group I: Liver-Link Arm Experimental Treatment 1 Intervention

Those randomized to the Liver-Link portion of the study will proceed through the Liver-Link component intervention. Participation in this study will last 6 months. Participants in this group are assessed for knowledge of their disease, quality of life, substance use, and for social needs at the beginning of the program. Those who screen positive for social needs or high-risk alcohol will see social work. Participants will attend 3 support groups and compelte exit surveys. Participants will have 3 milestone checks during the 6 month study period and will be referred back to social work if they do not meet milestones. Participants will also have a knowledge assessment after a total of 2 HCC-related visits.

Group II: Standard of Care Arm Active Control 1 Intervention

Individuals in the standard of care portion of the study will complete several questionnaires at the enrollment visit . Over the duration of study participation (6 months), participants in this arm may meet with a social worker as part of their standard health care treatment and will receive education via these standard of care visits. After at least two visits related to HCC clinical care, and participants in this arm will be contacted and will be asked to complete the knowledge assessment tool. At tne end of study they will complete exit survieys via redcap or phone.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The FDA's guidance on evaluating drug-induced liver injury (DILI) is effective for most low-risk populations but presents challenges for patients with existing liver diseases, such as viral hepatitis or cancer.

There is a pressing need for clearer guidelines and consensus on liver safety assessments, particularly regarding stopping rules based on ALT levels, to facilitate the approval and use of new antiviral and cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver safety assessment in special populations (hepatitis B, C, and oncology trials). Kullak-Ublick, GA., Merz, M., Griffel, L., et al.[2022]

The study identified 504 cases of drug-induced liver injury (DILI) associated with antibody-drug conjugates (ADCs) from the FAERS database, indicating a potential safety concern with these treatments.

Specific ADCs, including trastuzumab emtansine and enfortumab vedotin, were linked to DILI, suggesting the need for further research to understand the mechanisms and develop preventive strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pharmacovigilance study on drug-induced liver injury associated with antibody-drug conjugates (ADCs) based on the food and drug administration adverse event reporting system. Sun, C., Yang, X., Tang, L., et al.[2023]

In a review of 1670 patients from phase 1 oncology trials, only 4.9% developed drug-induced liver injury (DILI), indicating that while DILI can occur, it is relatively uncommon and often resolves with supportive care.

Rechallenging patients with a history of DILI carries a 28% risk of recurrence, particularly associated with higher peak alanine aminotransferase levels during the initial episode, suggesting careful consideration of treatment options is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implications of drug-induced liver injury in early-phase oncology clinical trials. Mondaca, SP., Liu, D., Flynn, JR., et al.[2022]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06728293

NCT06728293 | Effect of the HCC Liver-Link Intervention

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8237792/

Real-World Data on Clinical Outcomes of Patients with ...

Overall treatment compliance to the NCCS guidelines was 79.2%. Superior median OS was observed in patients receiving treatment compliant with NCCS guidelines ...

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trial.medpath.com

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Effect of the HCC Liver-Link Intervention | MedPath

Primary outcomes are time to receipt of curative therapies (liver transplantation or resection) and change in HCC-related knowledge. Findings will inform ...

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nature.com

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Hepatocellular carcinoma: signaling pathways and ...

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Reported success rates in downstaging HCC vary widely from 24% to 90%, likely influenced by the chosen downstaging treatment, initial tumor ...

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ascopubs.org

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Median overall survival reached 20.6 months in patients with preserved liver function and good performance status. Liver function (albumin- ...

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withpower.com

withpower.com/trial/liver-link-intervention-for-liver-cancer-7bbfd

Liver Link Intervention for Liver Cancer

Primary outcomes are time to receipt of curative therapies (liver transplantation or resection) and change in HCC-related knowledge. Findings will inform ...

8.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12780-y

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Our findings suggest that, in terms of overall efficacy and safety, regorafenib and cabozantinib are the optimal second-line treatment options ...