Trial Comparing PLA to HIGRT (PROVE-HCC)

Phase II Randomized Trial Comparing Percutaneous Ablation to Hypofractionated Image-Guided Radiation Therapy in Veteran and Non-Veteran, Non-surgical Hepatocellular Carcinoma Patients (PROVE-HCC)

This phase II, randomized trial compare Quality of Life for patients with Hepatocellular Carcinoma (HCC) who are not surgical candidates or decline surgery and are treated with Percutaneous Local Ablation (PLA) or Hypofractionated Image-Guided Radiation Therapy (HIGRT).

Administrative clarification:

This clinical trial was terminated due to poor enrollment and was replaced by a separate non-randomized trial (NCT04933435).

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