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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with resectable HCC who are still candidates for locoregional therapy

Patients receiving prior systemic or locoregional therapy

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Comprehensive Geriatric Assessment (CGA)

    Other intervention

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

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Group 11 intervention
Group B: Group 20 interventions

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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