NCT04933435Recruiting
Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
This is a research study to evaluate change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30), from baseline to 1 month post treatment in two patient cohorts receiving Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 17 Jun 2021
- Start date
- 12 Nov 2020
- Primary completion date
- Feb 2028
- Lead sponsor
- Duke University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04933435
What you commit to
- Study type: Interventional
- Planned participants: 78
- From 12 Nov 2020 to the primary completion date, Feb 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent administration of systemic therapy for hepatocellular carcinoma
- Prior liver radiation therapy is an exclusion unless subject participation is approved by the PI
Other
- Child Pugh score B9 or Class C
- Fluctuating ascites
- Inability to complete baseline Quality of Life survey forms
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Cancer Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Durham Veterans Administration Health Care System (DVAHCS) Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.