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National Liver Cancer Screening Trial

ConditionsCarcinoma, HepatocellularLiver CancerLiver CirrhosisHepatitis B
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Texas Southwestern Medical Center

About this trial

The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment

Patient is eligible for HCC surveillance according to treating physician or by the site investigator

Able to provide informed consent

Life expectancy >6 months (after consent) as determined by the treating provider or site investigator

Disqualifiers

Child Pugh C cirrhosis

History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma

History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI demonstrating benign nature)

AFP >20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions

Trial design

Design model

Parallel

Treatments tested in this trial

  • GALAD

    Diagnostic test

    GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.

  • Liver Ultrasound with or without AFP

    Diagnostic test

    This intervention consists of current standard of care ultrasound based surveillance with or without alpha-fetoprotein measurement.

Treatment groups

5,500 Participants
are divided into 2 treatment groups
Group A: Arm A: Semi-annual surveillance using liver ultrasound +/- alpha-fetoproteinActive comparator 1 intervention
Group B: Arm B: Semi-annual surveillance using GALADExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of HCC detected at late stage

Proportion of HCC detected at a late stage, defined as HCC beyond Milan Criteria (one tumor less than or equal to 5 cm or 2-3 tumors each less than or equal to 3 cm, in the absence of vascular invasion or extra-hepatic metastases)

Time frame
5.5 years

Secondary outcomes

1

HCC Screening utilization

Defined as proportion time covered by screening; each completed screening test (US +/- AFP or GALAD) will provide up to six months of coverage (numerator) divided by the total follow-up for each patient.

Time frame
5.5 years
2

Proportion of HCC detected at a late-stage (defined based on BCLC stage)

Defined as HCC beyond BCLC stage A (single tumor of any size without vascular invasion or extrahepatic spread; or 2-3 tumors equal to or less than 3 cm each, without vascular invasion or extrahepatic spread)

Time frame
5.5 years
3

Incidence of late-stage HCC

Defined as incidence of HCC (extended follow-up) beyond Milan Criteria or BCLC stage A

Time frame
8 years
4

Proportion of HCC cases that receive Curative therapy

Defined as count of participants in receipt of liver transplantation, surgical resection, local ablative therapy, or radiation segmentectomy

Time frame
5.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of Pennsylvania

Collaborator

University of Michigan

Collaborator

Dana-Farber Cancer Institute

Collaborator

Baylor College of Medicine

Collaborator

Fred Hutchinson Cancer Center

Collaborator

The Cleveland Clinic

Collaborator

Source ClinicalTrials.gov
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