Singapore General Hospital (SGH) today announced that an interim analysis by an Independent Data Safety Monitoring Committee has found that the SIRveNIB regional phase III investigator-initiated trial to be on track and has met its primary safety end points.
The primary responsibility of the Committee is to ensure the validity and integrity of the trial by performing on-going safety monitoring, as well as interim analysis for efficacy. For the SIRveNIB trial, the Committee has found it to be safe and recommends the trial to be completed without any changes to the trial protocol.
“We are delighted with the progress of this trial. This is an important trial to look at different treatment options for primary liver cancer. We hope the outcome of the trial, when available will be able to provide good information to the doctors in the region in treating this disease”, said Professor Pierce Chow, Senior Consultant, Department of General Surgery, SGH and Protocol Chair (Principal Investigator) of the trial.
The trial seeks to assess the effectiveness of two widely-used treatments (Sorafenib and SIR-Spheres) for locally advanced hepatocellular carcinoma (HCC) or liver cancer that has not spread outside of the liver. The aim is to determine which of these two therapies is more effective in the treatment of the disease. To date, about 200 patients have been recruited for the 360-patient clinical trial that is expected to complete in 2015.
Launched in July 2010, the trial is initiated under the Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC) and involves 28 centres in 11 countries including Korea, Hong Kong, New Zealand and Malaysia. It is jointly funded by the National Medical Research Council, Singapore and Sirtex with operational support by Singapore Clinical Research Institute (SCRI).
“This trial has shown that Singapore is able to coordinate large scale investigator-initiated clinical trials in the Asia Pacific region through good collaborations with the clinicians in the other countries,” said Dr Teoh Yee Leong, Chief Executive Officer, SCRI.
HCC is the 5th most common cancer worldwide. Almost 80 per cent of HCC cases are found in the Asia-Pacific region. As the majority of patients with liver cancer do not develop any symptoms, only one in five of them can potentially be cured by surgery when diagnosed.
About SIRveNIB Trial
Eligible patients who are enrolled in the trial will either undergo oral therapy, taking two tablets of Sorafenib twice a day for as long as the drug continues to be efficacious and the patient has minimal side-effects; or a single administration of SIRT (Yttrium-90) through a microcatheter directly into the liver.
Patients must meet the following inclusion criteria to be enrolled into the study:
• Must be at least 21 years of age
• Must be willing to comply with study-related procedures and tests
• Must have locally advanced liver cancer (i.e. the cancer has not spread to other organs)
• Must have locally advanced liver cancer that cannot be treated by surgery or other curative therapies
• Must be independent and able to perform daily living activities
• Must have adequate bone marrow, liver and renal function
• Must not have received any systemic chemotherapy for the past 6 months
• Must not have had more than two administrations of hepatic artery – directed therapy, or received hepatic artery – directed therapy less than 4 weeks prior to study entry
• Must not have received prior hepatic radiation therapy for HCC or other malignancy