Trial Comparing PLA to HIGRT (PROVE-HCC) (PROVE-HCC)
Hepatocellular Carcinoma

About this trial
This is an interventional other trial for Hepatocellular Carcinoma focused on measuring Unresectable
Eligibility Criteria
Inclusion Criteria:
- HCC diagnosed either by histology/pathology or Liver Imaging Reporting and Data System (LIRADs 5 per the ACR's LIRADs criteria) by CT or MRI
- Patient is 18 years or older
- ECOG Performance status of 0-2
- Child Pugh score A5, A6, B7 or B8
- Lesions less than or equal to 5cm in size
- Less than or equal to 3 lesions in the liver to be treated on protocol
- Lesion amenable to treatment with both PLA and HIGRT; for PLA treatment this requires the lesion be visible via ultrasound and/or non-contrast CT or feasible per treating physician
Exclusion Criteria:
- Child Pugh score B9 or Class C
- Fluctuating ascites
- Inability to complete baseline QOL forms
- Concurrent administration of systemic therapy for HCC
- Prior liver RT is an exclusion unless subject participation is approved by the PI
- Positive serum pregnancy test
Sites / Locations
- Durham Veterans Administration Medical Center (DVAMC)
- Duke Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Percutaneous Local Ablation (PLA)
Hypofractionated Image-Guided Radiation Therapy (HIGRT)
A PLA procedure uses high-energy radio waves to treat liver tumors. Using CT and ultrasound guidance the doctor inserts a thin, needle-like probe into the liver tumor A high-frequency current is then passed through the tip of the probe, which heats the tumor with the goal to destroy the cancer cells. This may be done as an outpatient procedure or a short (1-2 day) hospital stay. PLA is the standard treatment for patients with liver cancer who cannot undergo liver surgery.
HIGRT is an emerging treatment option for patients with HCC; it utilizes external radiation where multiple beams enter the body from multiple angles to treat the liver cancer over typically 5-10 treatments while minimizing radiation to normal tissues. You will receive between 5-10 fractions (treatments) of radiation. Fraction size will be either 5 or 10 Gy (pronounced Gray, a standard unit of radiation measurement) depending on your tumor size and location or underlying liver function. The total dose of radiation is 50 Gy.