Multi-national Clinical Study on Locally Advanced Liver Cancer (Hepatocellular Carcinoma)
The SIRveNIB (AHCC06) Randomised Controlled Trial.

 

WELCOME to the SIRveNIB website   

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


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.

 

ctscan
CT scan of Advanced Hepatocellular Carcinoma

 


 

 Summary of Current Treatment:

  • Surgery
  • Liver Transplantation
  • Molecular-targeted chemotherapy with the drug sorafenib
  • Chemo-embolization
  • Selective Internal Radiation Therapy (SIRT) with yttrium-90

 


 

THE SIRveNIB Trial

 

Trial Title

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

 

Study Treatment

 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
  OR
- 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

  • Age 18 years and above
  • Must be willing to comply with study related procedures and tests
  • Have locally advanced Liver Cancer (i.e. not spread to any other organs)
  • Cannot be treated by liver surgery or other curative therapies.
  • Is independent with activities of daily living and ambulatory
  • Adequate bone marrow, liver and renal function
  • Must not have received any systemic chemotherapy for the past 6 month
  • Must not have received >2 administration of hepatic artery directed therapy (i.e. Transarterial Chemo-Embolisation)
  • Must not have received prior hepatic radiation therapy (i.e. Selective Internal Radiation Therapy)
  • Must not have had prior treatment with Sorafenib or VEGF inhibitors

 

Clinical Trial Protocol Chair:



    

Professor Pierce Chow
Singapore General Hospital
National Cancer Center, Singapore
Duke-NUS Graduate Medical School

Co-ordinating Body:



  This multi-center trial is coordinated by
the Singapore Clinical Research Institute
This email address is being protected from spambots. You need JavaScript enabled to view it.
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.

 

Recruitment Target

360 patients to be recruited in the Asia-Pacific (including New Zealand) from the medical centres.

 

Interim Analysis

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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