Sirtex Medical (ASX:SRX) has announced the launch of a new randomised controlled clinical study of SIR-Spheres Y-90 resin microspheres in patients with unresectable Intrahepatic Cholangiocarcinoma, also known as iCCA.
The study, known as SIRCCA, is a prospective, multi-centre, randomised, controlled clinical study evaluating SIR-Spheres Y-90 resin microspheres preceding cisplatin-gemcitabine (CIS-GEM) chemotherapy versus CIS-GEM chemotherapy alone as a first-line treatment of patients with unresectable iCCA.
Although a relatively rare disease, iCCA is the second most common form of primary liver cancer and starts in the bile duct, with an annual incidence of approximately 5,000 patients in the US, which appears to be increasing.
SIRCCA is expected to recruit 180 patients and is being conducted in 30 centres across Australia and Europe. The company said the first patient is expected to be recruited into the study prior to the end of calendar year 2016, with the study anticipated to complete recruitment in late 2018.
Mr Gilman Wong, CEO of Sirtex Medical, said: “The initiation of the SIRCCA study reflects the continued investment into our SIR-Spheres microspheres business to generate further clinical evidence to support new regulatory applications and product reimbursement. iCCA is a particularly attractive opportunity for Sirtex, where the use of our product has already shown promise and treatment options are very limited for these patients, while survival rates remain poor. This study, coupled with the inclusion of SIR-Spheres microspheres into the recent ESMO clinical practice guidelines for iCCA, will help us to build awareness and grow dose sales over time for this important disease.”
The use of yttrium-90 (Y- 90) microspheres for the treatment of iCCA was highlighted at the recent European Society of Medical Oncology (ESMO) meeting following publication of clinical practice guidelines on biliary cancers as a supplement to the Annals of Oncology. 2
Dr David Cade, Chief Medical Officer of Sirtex Medical, said: “We are delighted to see SIRSpheres Y-90 resin microspheres cited as an important post-chemotherapy option for patients with locally advanced or metastatic iCCA, given no current standard of care exists beyond first-line treatment with cisplatin and gemcitabine chemotherapy in these patients. We believe that these are the first international clinical guidelines to include SIRT as a treatment option for patients with iCCA.”
He continued, “This new clinical practice guideline from ESMO comes at a significant time for Sirtex, given our new SIRCCA study across Europe and Australia. We anticipate the ESMO guideline will be an important catalyst to drive awareness on the use of SIR-Spheres microspheres in iCCA across Europe, and accordingly we would expect to receive a benefit in our ability to recruit patients onto the SIRCCA study. This study will be the largest ever interventional oncology study undertaken in this rare, but important disease, where prospective randomised data are lacking.”