This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible.
This intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors.
Tumor response rate
Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months
Time frame: 3 months
Tumor down staging
Incidence of down staging of stage B or C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months
Time frame: 3 and 6 months
Frequency of adverse events
Incidence of Grade 3 or 4 adverse events associated with SBRT for liver tumors
Time frame: 6 months
Incidence of local tumor progression
Incidence of local progression as demonstrated by radiological imaging (RECIST criteria)
Time frame: 6 months
Number of patients eligibility for liver transplantation
Number of patients achieving sufficient tumor response to attain eligibility for liver transplantation.
Time frame: 3 months
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