Evaluating liver cancer treatments and their impact on quality of life
Official title: Phase II Non-Randomized Trial of Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
Run by Duke University · NCT04933435 · Data updated 2026-11-12
This study is testing how two different liver cancer treatments affect the quality of life for patients with hepatocellular carcinoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | November 12, 2020 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT04933435 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older diagnosed with hepatocellular carcinoma who meet specific clinical criteria.
✕Probably not a fit
Patients with advanced liver disease (Child Pugh score B9 or Class C) or those receiving concurrent systemic therapy for HCC may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the change in quality of life for patients with hepatocellular carcinoma (HCC) undergoing either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy. Participants will complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) to measure their quality of life from baseline to one month post-treatment. The study includes both veteran and non-veteran patients, focusing on those with specific eligibility criteria related to their liver cancer diagnosis and treatment options.
Why it matters
Potential benefit: If successful, this study could provide insights into how different liver cancer treatments affect patients' quality of life.
How similar studies have gone: Other studies have explored similar treatment approaches for liver cancer, but this specific combination of therapies and focus on quality of life is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria 10) by CT or MRI * Patient is 18 years or older * ECOG Performance status of 0-2 * Child Pugh score A5, A6, B7 or B8 (see Appendix) * Lesion ≤ 5cm in size * ≤ 3 lesions in the liver to be treated on protocol * Lesion amenable to treatment with both Interventional Radiology Liver Directed Therapies and HIGRT. Exclusion Criteria: * Child Pugh score B9 or Class C * Fluctuating ascites * Inability to complete baseline Quality of Life survey forms * Concurrent administration of systemic therapy for hepatocellular carcinoma * Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI
Where it's running
-
Durham Veterans Administration Health Care System (DVAHCS)
Durham, North Carolina, United States Recruiting -
Duke Cancer Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Manisha Palta, MD — Duke Health
- Study coordinator: Heather Franklin
- Email: heather.mccullough@duke.edu
- Phone: (919) 668-3726
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.