Top clinician investigators to embark on major multi-centre clinical trial that can prolong the lives of liver cancer sufferers

Singapore, 16 June 2008 – A team of clinician investigators is embarking on a major clinical trial involving two treatment modalities, which, if successful, can prolong the life spans of liver cancer patients. Both treatments are separately available in the international market for the treatment of liver cancer.

This investigator-initiated multi-centre trial is carried out under the auspices of the AsiaPacific Hepatocellular Carcinoma (AHCC) Trials Group, which has its secretariat at the National Cancer Centre Singapore (NCCS). Various member-centres around the region are also invited to participate in the trial, namely, China, India, Indonesia, South Korea, Malaysia, Myanmar, New Zealand, Philippines, Thailand, Taiwan and Vietnam.

The trial’s steering committee comprises of research scientists and clinician investigators from the following leading institutions:

Protocol Chair:

A/Prof Pierce CHOW
Senior Consultant Hepato-Biliary Surgeon
Singapore General Hospital

Members:

Prof SOO Khee Chee
Director
National Cancer Centre Singapore

A/Prof TAN Say Beng
Director
Clinical Trials and Epidemiology Research Unit

Dr Anthony GOH
Head, Department of Nuclear Medicine
Singapore General Hospital

Dr TAY Kiang Hiong
Senior Consultant, Department of Diagnostic Radiology
Singapore General Hospital

Dr Richard LO
Senior Consultant, Department of Diagnostic Radiology
Singapore General Hospital

Dr Donald POON
Consultant, Department of Medical Oncology
National Cancer Centre Singapore

Prof Soo Khee Chee, NCCS Director, who is also the Group Chair of AHCC Trials Group, said: “Almost 80% of hepatocellular carcinoma or liver cancer are found in Asia. Yet, there has been, until recently, little research carried out on this disease. The AHCC Trials Group, with the support from Singapore Millennium Foundation, was thus formed with like-minded clinicians in the region. Their objective is to pioneer new treatment modalities for liver cancer patients especially those with advance disease which generally has a median survival of less than three months.”

“This trial is an important milestone for all our researchers and clinician investigators because we will be taking a step forward in our efforts to help our patients combat liver cancer.”

Altogether this phase I/II trial will involve 31 patients, including those from regional centres. They will use a combination of two treatment modalities instead of the current standard practice of putting such patients on either one of these treatments. This trial will begin this month in Singapore and is expected to be completed within two years.

Currently, patients who go on Sorafenib, an oral targeted chemotherapy drug, have shown a significant overall survival by 47% or an ability to extend their life spans by about three months. Patients who were given SIR-Spheres, which is an internal radiation therapy applied directly to liver cancer through a catheter, have reported significant tumour regression. The trial will be considered successful if administering both treatments can prolong the patient’s life longer than this period.

Commenting on how the trial will be facilitated, A/Prof Pierce K.H. Chow said: “Patients from centres outside of Singapore will be flown here for the administration of SIR-Spheres as Singapore is equipped with the facilities to do so, with close monitoring by AHCC. Once home, they will then be given Sorafenib and be followed up by their respective trial centres. ”

Sorafenib will cost a patient approximately S$9,000 a month at NCCS. This drug is awaiting approval from Health Sciences Authority (HSA) for use in Singapore for liver cancer although in many other countries, it has already been approved. Currently in Singapore, approval is only given for use in renal cell carcinoma. SIR-Spheres, which can cost about S$15,000 per patient for the product alone, has been approved by HSA since year 2005.

This project is supported by the National Medical Research Council (NMRC), drug manufacturer, Bayer Schering Pharma Singapore and bio-technology company, Sirtex Medical Products. The drug Sorafenib is manufactured by Bayer Schering Pharma Singapore, and SIR-Spheres is a medical device of Sirtex Medical Products. Both companies are each funding approximately S$1.5 million in therapeutics and the NMRC is providing S$468,200.

Five patients from Singapore have already been identified and they will be put on the clinical trial within weeks. The HSA has given its approval for the trial to be carried out.

These patients were picked because their liver cancers were considered inoperable and going on this trial offers them the potential opportunity for longer survival.

In phase I of the trial, three patients will be given Sorafenib 14 days after being infused with SIR-Spheres. If found to be free from adverse effects, another three patients will be given Sorafenib 11 days post SIR-Spheres before the rest of the patients are put on this combination. Results from the use of the combined treatments will be revealed at the end of the Phase II trial. This may lead to a Phase III of the trial if the results are significant.

The public can call +65 6326 6337 if they wish to find out more about the trial.

Click here to view the media release.