Storm - sorafenib as an adjuvant treatment in liver cancer

• Research type

  Research Study

• Full title

  A Phase III randomised, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation.

• IRAS ID

  343

• Sponsor organisation

  Bayer Healthcare AG

• Eudract number

  2008-001087-36

• ISRCTN Number

  N/A

• Research summary

  No treatments are available for the prevention of liver cancer returning when it has been removed after procedures including surgery or ablation (destruction). The study drug, sorafenib, is approved for the treatment of liver cancer, but the purpose of this study is to assess if sorafenib can reduce the risk of liver cancer returning, after procedures to remove it.Over 39,000 cancer patients have taken sorafenib either as single treatment or together with other chemotherapy drugs for several types of cancer. Sorafenib works by stopping the development of new cancer cells and new blood vessels which prevents the growth of tumours.Two Sorafenib or placebo tablets will be taken by mouth twice a day. Treatment will continue for a maximum of 4 years or until the cancer returns or spreads to other parts of the body or if intolerable side effects are experienced.The main aim of the study is to evaluate effectiveness and safety of sorafenib versus placebo in preventing the return of liver cancer after potentially curative treatment with surgery or ablation by examining how long patients remain free of the cancer, the time taken for the cancer to return and the overall survival of patients.

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  08/H1204/138

• Date of REC Opinion

  10 Dec 2008

• REC opinion

  Further Information Favourable Opinion