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Liver Cancer Treatment Study: Interventional Radiology vs. Radiation Therapy

This study is for people with liver cancer (hepatocellular carcinoma or HCC) who are not able to have surgery. It compares two ways to treat liver cancer: Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy. Researchers want to see how these treatments affect your quality of life, using special questionnaires. You might be able to join if you are 18 or older, have HCC diagnosed by imaging or biopsy, and have up to three liver lesions (tumors) that are 5cm or smaller. The study aims to enroll 78 participants. The current recruitment status is unclear.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 78 participants.
What's involved
You would complete quality of life questionnaires at the start of the study, and then again at 1 month, 3 months, and 6 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in quality of life at 1 month, 3 months, and 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04933435

Interventional Radiology Liver Directed Therapies and Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients

Recruiting
NAAges 18+InterventionalSupportive care
Duke University
~78 participants
Updated 2025-11-19 on ClinicalTrials.gov
What's tested:Quality of life questionnaires

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy
Measured over baseline, 1 month, 3 months, 6 months

Conditions

Liver Cancer

Explore related trials

Hepatocellular Carcinoma

NCT04933435

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke Cancer Center

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Durham Veterans Administration Health Care System (DVAHCS)

    Durham, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Manisha Palta, MD · PRINCIPAL_INVESTIGATOR · Duke Health

Who to contact

Heather Franklin
[email protected]
(919) 668-3726
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapybaseline, 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)