Centres Open For Recruitment:
Click for contact details
CHINA - HONG KONG
Multi-national Clinical Study on Locally Advanced Liver Cancer (Hepatocellular Carcinoma)
The SIRveNIB (AHCC06) Randomised Controlled Trial.
This website has been designed to provide you with information about primary liver cancer (hepatocellular carcinoma or HCC) and the clinical trial SIRveNIB for liver cancer patients in the Asia Pacific region. Our goal is to provide liver cancer patients and their families with relevant knowledge of liver cancer and with information of this clinical trial (SIRveNIB).
Hepatocellular Carcinoma (HCC) is the 6th most common cancer in the world and afflicts almost a million people yearly. There is however great geographical variation in the distribution of HCC and 80% of this cancer found in the Asia-Pacific region. In Asia it is the 3rd most common cancer. While surgical resection (and in some cases liver transplantation) offers patients with HCC the most consistent and significant survival advantage, less than 20 % of HCC can receive surgery as a therapy. This is because of the advanced stage of the disease at the time of diagnosis.
Another 30% of inoperable patients may benefit from other existing therapies that prolong lives but the outcome and survival of the remaining inoperable patients remains grave. Even in the group of patients treated with surgical resection, long term survival has remained unsatisfactory because of recurrent carcinoma and progressive liver disease.
Chemoprevention in patients at high risk for HCC has also not been clearly established. There is thus an urgent need for more clinical trials in HCC (palliative, adjuvant and chemoprevention) to develop new and efficacious therapies, especially in parts of the world where the disease burden is highest. Clinical trials on cutting-edge therapies allow patients to have timely access to and benefit from such therapies.
Summary of Current Treatment:
- Liver Transplantation
- Molecular-targeted chemotherapy with the drug sorafenib
- Selective Internal Radiation Therapy (SIRT) with yttrium-90
THE SIRveNIB Trial
PHASE III MULTI‐CENTRE OPEN‐LABEL RANDOMIZED CONTROLLED TRIAL OF SELECTIVE INTERNAL RADIATION THERAPY (SIRT) VERSUS SORAFENIB IN LOCALLY ADVANCED HEPATOCELLULAR (AHCC Protocol 06)
This clinical trial is an investigator-initiated, multi-centre study initiated under the Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC) which has its secretariat in Singapore. This is the 6th multi-centre liver cancer trial that the trials group is conducting. Click here to go to AHCC website
Eligible subjects will receive either:
- An oral therapy of sorafenib tablet, twice a day for as long as the drug continues to be efficacious and the patient has minimal side-effects. Click here for information on Sorafenib
- A single administration of SIRT (Yttrium-90) directly into the liver. Click here for information on SIR-Spheres
Eligible patients who are enrolled in the trial will receive either of the treatment above at no cost. Sorafenib will be administered at individual trial centres within the multi-centre trial group. SIR-Spheres therapy will be administered at the local centre where facilities exisit, or at designated trial centres in the Asia-Pacific.
Rationale of Study
The study is conducted to evaluate the effectiveness of 2 widely-used treatments (sorafenib and SIR-Spheres) for locally advanced liver cancer i.e. cancer that has not spread outside of the liver. The aim is to determine which of these 2 therapies is more effective in the treatment of this disease.
In order to enrol into the study, subjects must meet a number of inclusion and exclusion criteria. The key criteria are listed below.
Key Inclusion Criteria
Clinical Trial Protocol Chair:
Professor Pierce Chow
|This multi-center trial is coordinated by
the Singapore Clinical Research Institute
Please submit your enquiry here
*If you have locally advanced liver cancer and think you have met all of the above criteria, you may contact the various participating centres listed below.
360 patients to be recruited in the Asia-Pacific (including New Zealand) from the medical centres.
The SIRveNIB Data Safety and Monitoring Board (DSMB) met for the first time on 22nd May 2013. A DSMB is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. The DSMB reviewed an interim analysis of the trial data, including subject safety and efficacy data, and concluded that the trial is safe, on-track, and can continue to recruit patients. For more information, please click here to read the Singapore General Hospital press release.
This study is supported by National Medical Research Council (NMRC) Singapore and Sirtex Technology Pty Ltd.
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