Carcinoma, HepatocellularNCT03894917
Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
An observational study of Carcinoma, Hepatocellular, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Comprehensive Geriatric Assessment (CGA)
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2019to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed with advanced hepatocellular carcinoma (HCC) that cannot be removed with surgery.
Who may be able to join
- 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.
Who cannot join
- Patients with resectable HCC who are still candidates for locoregional therapy
- Patients receiving prior systemic or locoregional therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mays Cancer Center
San Antonio, Texas, 78229
Gina Alvarez, RN, 210-450-5893, alvarezg1@uthscsa.edu
About this study
Official title: Characterizing Disease Biology, Treatment Patterns and Toxicity in Older Adults With Advanced 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.
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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Comprehensive Geriatric Assessment (CGA)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric Assessment (CGA)Other
Assessments will be done for participants that are 65 years or older.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants 65 years or older Receives: Other: Comprehensive Geriatric Assessment (CGA) | |
| Group 2 | Participants less than 65 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: will be collected at time points: at screening, Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start13 Sep 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sukeshi Patel Arora, MD, Principal investigator, Mays Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894917
- Sponsor's protocol ID
- CTMS 19-0010
- Other IDs
- HSC20190202H
- Status last verified
- Jan 2026
- First submitted
- 27 Mar 2019
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Disease Biology, Treatment Patterns and Toxicity in Older Adults With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03894917
- Acronym / sponsor ID
- CTMS 19-0010
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Comprehensive Geriatric Assessment (CGA)Participants 65 years or older |
| Group 2 | – | –Participants less than 65 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed with advanced hepatocellular carcinoma (HCC) that cannot be removed with surgery.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with resectable HCC who are still candidates for locoregional therapy
- Patients receiving prior systemic or locoregional therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric Assessment (CGA)Assessments will be done for participants that are 65 years or older. | Other | Group 1 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Mays Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sukeshi Patel Arora, MD principal investigator
Mays Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maggie Tomasini, MPH (210-450-0507, tomasinim@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.