Trial Information

Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is
primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors
include alcoholic cirrhosis.

Outcome of this disease is poor, mostly due to the fact that >80% of patients present with
unresectable disease. Surgery or transplantation remain the only curative options. For the
vast majority of patients who are unresectable, a variety of treatment options are
available, including transarterial chemo-embolization (TACE), radiofrequency ablation,
radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and
percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body
radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available
because of great improvements in diagnostic imaging and radiation delivery techniques.
Although follow-up is limited, results show encouraging local control rates. Some
investigators have combined TACE with fractionated radiotherapy as a means of intensifying
local therapy, with some evidence of benefit.

TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence
rates are high. The recent randomized trial suggests that a combination of local therapy
(TACE and radiofrequency ablation [RFA]) is superior to either therapy alone, providing
proof of principle that combined local treatment is most likely more effective for HCC.
Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in
treating HCC needs to be further defined. Studies combining TACE and external beam
radiotherapy have shown encouraging results, so the logical next step is to combine TACE
with SBRT, which delivers a radiobiologically more intensive dose of radiation. However,
toxicity data are lacking, since this combination has not been previously reported.

We propose to conduct a trial of trans-arterial chemo-embolization (TACE) and SBRT for
unresectable HCC.