Recruiting

Liver Directed Therapies

Sponsor:

Duke University

Code:

NCT04933435

Conditions

Liver Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality of life questionnaires

Study Details

Brief 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 Hypofractionated Image-Guided Radiation Therapy.

Conditions

Liver Cancer

Study ID

NCT04933435

Start date

Nov 12, 2020

Status verified date

Nov, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

78 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Interventional Radiology Liver Directed Therapies (ILDT)

ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization.

active comparator: Hypofractionated Image-Guided Radiation Therapy (HIGRT)

HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation.

Interventions

Quality of life questionnaires

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)

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 ]

Central Contacts and Locations

Central contacts

Heather Franklin

(919) 668-3726heather.mccullough@duke.edu

Linda Kaltenbach, PhD

Linda.Kaltenbach@duke.edu

Locations

Durham Veterans Administration Health Care System (DVAHCS)

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Josephine Gaston, BSN RN

Josephine.Gaston@va.gov

Principal Investigator:

Manisha Palta, MD

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Heather Franklin

919-668-3726heather.mccullough@duke.edu

Principal Investigator:

Manisha Palta, MD

More Information

Sponsor

Duke University

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-11-19.