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NCT Number: NCT03894917

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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mays Cancer Center

San Antonio, Texas, 78229, United States

Location status: Recruiting

Location contact

Gina Alvarez, RN

CONTACT

[email protected]

210-450-5893

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

comprehensive geriatric assessment (CGA)

Other

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

Primary outcomes

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

    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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Maggie Tomasini, MPH

CONTACT

[email protected]

210-450-0507

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Mar 29, 2019
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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