FOR PATIENTS
FOR CLINICIANS
FOR THE PRESS
THE EXPERTS GROUP
MEDIA POOL
> SIRT > Home > SORAMIC study
 

SORAMIC

 

Study title

 

Evaluation of Sorafenib in Combination With Local Micro-therapy Guided by Gd-EOB-DTPA Enhanced MRI in Patients With Inoperable Hepatocellular Carcinoma. (SORAMIC)

www.soramic.com
http://clinicaltrials.gov/ct2/show/NCT01126645

This study tests, among other things, how efficient the combination of Selective Internal Radiation Therapy (SIRT) with SIR–Spheres® microspheres and the drug sorafenib is in patients with inoperable liver cell cancer (hepatocellular carcinoma, HCC). A first patient group is being treated exclusively with sorafenib. A second patient group is initially receiving SIRT and then the active substance sorafenib. The study will provide information on whether the combination of sorafenib and SIR-Spheres microspheres can prolong the overall survival of patients with advanced liver cancer.

  • Diagnosis: Hepatocellular carcinoma (HCC, liver cell cancer)
  • Primary or exclusive involvement of the liver
  • No suitability for trans-arterial chemo-embolisation (TACE)
  • BCLC status: A, B, C
  • Child-Pugh classes: A & B ≤ 7 points
  • Adequate haematological function, bilirubin level no more than 1.5 x elevated, ECOG performance status <2
  • Life expectancy of more than 4 months
  • No metastases in the lungs
  • Adequate renal function (GFR > 30 mL/min/1.73 m2)
  • Tumour involvement of the entire liver less than 70 per cent
  • No malignant tumours within the last five years (except skin or cervical cancer)
  • No previous organ transplants
  • No previous external radiotherapy of the liver
  • No previous treatment with monoclonal antibodies
  • No participation in other clinical studies
  • No episodes of severe bleeding within the last 30 days prior to study enrolment
  • No uncontrolled ascites or hypertension
  • No impaired immunity or inflammatory bowel disease

 

Further criteria can be viewed be clicking this link: http://clinicaltrials.gov/ct2/show/NCT01126645

 

The following hospitals and clinics in Germany, Austria and Switzerland will also be happy to answer any queries you may have. have.

 
NEWS & DATES
More treatment options are necessary for patients with metastatic colorectal cancer – Colorectal cancer prevention is getting more and more attention. However, every third colorectal cancer patient develops metastases in the course of the disease – often in the liver. For these patients, more and better therapy options are needed. Local therapies offer promising opportunities.To the press release
The new ESMO guidelines recommend SIRT for people with metastatic colorectal cancer if the metastases are limited to the liver and are not responding to chemotherapy.
New evidence of the benefits of SIRT in mCRC – The depth-of-response data from the SIRFLOX study shows a significantly larger local depth of response through the combination of SIRT and chemotherapy. To the press release
Metastatic colorectal cancer: the SIRFLOX, FOXFIRE and FOXFIRE Global studies are investigating the benefits of combining SIRT with chemotherapy. The data from the three studies regarding overall survival is expected by the end of 2017. The SARAH and SIRveNIB studies on advanced liver cell cancer are now complete. Both compared Y90 radio-embolisation with sorafenib chemotherapy. The initial results are set to be published at the end of 2016 (SARAH) and 2017 (SIRveNIB).
The SIRT Experts Group is a partner of: