SORAMIC

• Research type

  Research Study

• Full title

  Evaluation of Sorafenib in combination with local micro-therapy guided by Gd-EOB-DTPA enhanced MRI in patients with inoperable hepatocellular carcinoma

• IRAS ID

  149388

• Contact name

  Daniel Palmer

• Contact email

  daniel.palmer@liverpool.ac.uk

• Sponsor organisation

  Medical Faculty, University Magdeburg

• Eudract number

  2009-012576-27

• Clinicaltrials.gov Identifier

  NCT01126645

• Research summary

  The present study is an investigator initiated, multicenter, multinational trial in a total of 655 patients with HCC. The study consists of two parts: the diagnostic part and the therapeutic part. In the diagnostic part of the study, contrast-enhanced magnetic resonance imaging (MRI) and computed tomography (CT) will be compared to determine if MRI is at least comparable to CT in guiding initial treatment decisions and patient management. Clinical treatment decisions will be made by the investigator, unblinded, in real time; the diagnostic study will utilize a randomized, blinded-read design.
  In the therapeutic part, new combinations of therapeutic procedures shall be compared to today’s general practice. There is one study arm for patients with advanced HCC, and a second study arm for patients with less advanced HCC.
  • Patients with advanced HCC will be treated with Nexavar® (sorafenib), in accord with current practice. Approximately half of these patients will first receive local radiotherapy (randomized, open-label), with 90Y-labeled SIR-spheres® (medical device, CE). This substudy will determine if overall survival is extended by the additional therapy with SIR-spheres®. SIR-Spheres® are authorized for use in patients with inoperable HCC.

  • Patients with less advanced HCC will be treated with radiofrequency ablation (RFA), in accord with current practice. Subsequently, one half of the patients will receive Nexavar® and the other half, placebo (randomized, double blind). This substudy will determine if the use of Nexavar® extends the time to recurrence.
  The study captures patients with operable HCC (typically treated with RFA) and patients with inoperable HCC (typically treated either with 90Y-spheres or sorafenib).
  All study drugs are already market approved. The expected adverse reactions of Nexavar®, Primovist® and the SIR-spheres® were defined according to the details of the SmPC. The study participants will receive routine clinical treatment after the end of the clinical trial.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  14/NW/1027

• Date of REC Opinion

  23 Sep 2014

• REC opinion

  Further Information Favourable Opinion