Phase III Multi-Centre Open-Label Randomized Controlled Trial of Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (SIRveNIB)
Hepatocellular carcinoma (HCC) is the 5th most common cancer worldwide but unfortunately
between 70 - 80% of all HCC are in the Asia-Pacific because of the prevalence of chronic
viral hepatitis in the region. The increase in the prevalence of chronic hepatitis C in the
Western world however predicts that HCC will similarly be an important cause of death there
in the next 20 years.
Only 15-20% of HCC are today potentially curable by surgery at the time of diagnosis.
Another 10-15% of patients may benefit from potentially curative locally ablative therapy
such as radio-frequency ablation. Prognosis in the majority of patients has been dismal as
conventional systemic therapies have been largely inefficacious. The first successfully
trialed systemic targeted therapy, sorafenib (2007) prolonged survival by a modest average
of 3 months in patients with good underlying liver function.
While the liver is radio-sensitive, external beam radiation causes significant
radio-toxicity. To overcome this, selective internal radiation therapy (SIRT) was developed
to deliver a radiation source directly to liver cancer via the arterial route. Sir-sphere is
radioactive yttrium on a 90 micro-meter diameter resin carrier and is an established therapy
in colorectal metastasis. Sir-sphere has been reported to cause significantly tumour
regression in HCC.
This study will evaluate the efficacy of SIRT using SIR-Spheres yttrium-90 microspheres
compared to sorafenib in the treatment of patients with locally advanced primary HCC.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
Overall Survival is defined as the time from the date of randomisation to the date of death due to any cause. All patients will be followed up until death to compare the overall survival between the two treatments. 2 years is an estimated time frame.
2 years
No
Pierce KH Chow, MBBS, PhD
Study Chair
Singapore General Hospital
Singapore: Health Sciences Authority
AHCC06
NCT01135056
July 2010
July 2015
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