Liver CancerNCT04933435
Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients
A study testing Quality of life questionnaires in people with Liver Cancer and Hepatocellular Carcinoma (HCC), run by Duke University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hepatocellular Carcinoma (HCC)
- What is being tested?
- Quality of life questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Nov 2020to Feb 2028
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Linda Kaltenbach, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Durham Veterans Administration Health Care System (DVAHCS)
Durham, North Carolina, 27705
Josephine Gaston, BSN RN, Josephine.Gaston@va.gov
Joseph Salama, MD
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
Heather Franklin, (919) 668-3726, heather.mccullough@duke.edu
Manisha Palta, MD
About this study
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
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.
- Conditions
- Liver Cancer, Hepatocellular Carcinoma (HCC)
- Being tested
- Quality of life questionnaires
- Keywords
- Percutaneous local ablation (PLA), Hypofractionated Image-Guided Radiation Therapy (HIGRT)
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesOther
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep)
| Study group | Role | What they receive |
|---|---|---|
| Interventional Radiology Liver Directed Therapies (ILDT) | Active comparator | ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization. Receives: Other: Quality of life questionnaires |
| Hypofractionated Image-Guided Radiation Therapy (HIGRT) | Active comparator | HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation. Receives: Other: Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) measured from not at all (better) to very much (worse)
Measured: baseline, 1 month, 3 months, 6 months
Secondary outcomes (5)
change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT
as measured by the FACT-Hep survey questionnaire from not at all (better) to very much (worse)
Measured: baseline, 1 month, 3 months, 6 months
number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy
Measured: 90 days
number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy
Measured: 90 days
total healthcare system cost associated with Interventional Radiology Liver Directed Therapies
Measured: 90 days
total healthcare system cost associated with Hypofractionated Liver Directed Therapy
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start12 Nov 2020
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manisha Palta, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933435
- Sponsor's protocol ID
- Pro00089525_1
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04933435
- Acronym / sponsor ID
- Pro00089525_1
- Conditions
- Liver Cancer, Hepatocellular Carcinoma (HCC)
- Keywords
- Percutaneous local ablation (PLA), Hypofractionated Image-Guided Radiation Therapy (HIGRT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 21 Jun 2021 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Radiology Liver Directed Therapies (ILDT) | Active comparator | Other: Quality of life questionnairesILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization. |
| Hypofractionated Image-Guided Radiation Therapy (HIGRT) | Active comparator | Other: Quality of life questionnairesHIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Quality of life questionnairesEuropean Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) | Other | Hypofractionated Image-Guided Radiation Therapy (HIGRT), Interventional Radiology Liver Directed Therapies (ILDT) |
Primary outcome
change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
Time frame: baseline, 1 month, 3 months, 6 months
as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) measured from not at all (better) to very much (worse)
5 secondary outcomes
change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT
Time frame: baseline, 1 month, 3 months, 6 months
number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy
Time frame: 90 days
number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy
Time frame: 90 days
total healthcare system cost associated with Interventional Radiology Liver Directed Therapies
Time frame: 90 days
total healthcare system cost associated with Hypofractionated Liver Directed Therapy
Time frame: 90 days
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 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Linda Kaltenbach, PhD contact
Manisha Palta, MD principal investigator
Duke Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life questionnaires in people with Liver Cancer and Hepatocellular Carcinoma (HCC), run by Duke University at 2 sites 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 7 inclusion and 5 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Heather Franklin ((919) 668-3726, heather.mccullough@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy (time frame: baseline, 1 month, 3 months, 6 months). 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 22 Oct 2026.