NCT01135056

Study to Compare Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (HCC)

Phase III Multi-Centre Open-Label Randomized Controlled Trial of Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (SIRveNIB)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the efficacy of SIRT as compared with Sorafenib in patients with locally advanced liver cancer in terms of overall survival (OS). The Study null hypothesis is, there is no difference in overall survival between patients receiving SIRT and those receiving Sorafenib therapy.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DEVICE	SIR-Spheres	One time treatment. Dose administered based on tumour volume. Each vial is 3.0GBq.
DRUG	Sorafenib tosylate	Oral Tablet, 400mg B.i.d, until progression or unacceptable toxicity develops

Timeline

• Start date: 2010-07-01
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2010-06-02
• Last updated: 2018-04-24

Locations

29 sites across 12 countries: Brunei, Burma, China, Indonesia, Malaysia, Mongolia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand