CClinicalTrials.gg
RecruitingNCT03894917Updated Jan 8, 2026

Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma

An observational study in Carcinoma, Hepatocellular, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by The University of Texas Health Science Center at San Antonio · Observational

From the registry’s dates

  • Started Sep 2019; still recruiting 7 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
84
Ages
18 Years and older
Sex
All
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Study summary

This is an observational, prospective cohort study that will recruit a diverse sample of 84 participants with newly diagnosed with unresectable, advanced hepatocellular carcinoma (HCC) at the UT Health Cancer Center in San Antonio. This study uses geriatric assessment tools with participants 65 years and older and collects adverse events and exploratory markers of aging for all participants.

Read the detailed description

The results from this study will allow us to identify unique disease characteristics of older participants and to study treatment patterns that may be barriers to treatment and risk factors for increased morbidity. Characteristics of Comprehensive Geriatric Assessment will be obtained prior to standard interventional treatment for participants that are 65 years or older. Observations will be made of treatment toxicities and cellular senescence with treatment outcomes. Findings from this study will result in the development of R01 intervention studies that develop and validate a treatment algorithm based on these associations to provide older adults with a personalized treatment plan.

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Conditions studied

  • Carcinoma, Hepatocellular
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In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's planned enrollment of 84 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Newly diagnosed with advanced hepatocellular carcinoma (HCC) that cannot be removed with surgery.

Inclusion criteria

  • Histologically or radiographically (CT or MRI) confirmed newly diagnosed hepatocellular carcinoma.
  • Age 18 years and older.
  • Patients with advanced, unresectable HCC as determined by the treating physician.

Exclusion criteria

Exclusion Criteria:

  • Patients with resectable HCC who are still candidates for locoregional therapy
  • Patients receiving prior systemic or locoregional therapy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
84 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    Participants 65 years or older

    Other: Comprehensive Geriatric Assessment (CGA)

  • Group 2

    Participants less than 65 years

Interventions

  • OtherComprehensive Geriatric Assessment (CGA)

    Assessments will be done for participants that are 65 years or older.

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What researchers measure

Primary outcomes

  1. Characterize the Change in disease and treatment patterns of advanced hepatocellular carcinoma (HCC) in older patients in the US.

    Collection of the participants disease characteristics, clinical and treatment data. Comprehensive geriatrics assessments will be done using bilingual assessments in English and Spanish.

    Time frame: will be collected at time points: at screening, Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12.

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Study locations

1 of 1 sites recruiting
  • Mays Cancer Center
    San Antonio, Texas 78229, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03894917
Lead sponsor
The University of Texas Health Science Center at San Antonio
Responsible party
Sponsor
First posted
Mar 29, 2019
Start date
Sep 13, 2019
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 8, 2026

Study contacts

Maggie Tomasini, MPH
Contact
tomasinim@uthscsa.edu
210-450-0507
Sukeshi Patel Arora, MD
principal investigator · Mays Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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