Sorafenib+Erlotinib/Placebo in Advanced HCC

• Research type

  Research Study

• Full title

  A Phase III randomized, placebo controlled, double blind trial of Sorafenib plus Erlotinib vs. Sorafenib plus placebo as First Line systemic treatment for Hepatocellular Carcinoma (HCC)

• IRAS ID

  10726

• Contact name

  Jeff Evans

• Contact email

  j.evans@beatson.gla.ac.uk

• Sponsor organisation

  Bayer Healthcare AG

• Eudract number

  2008-006021-14

• Clinicaltrials.gov Identifier

  00901901

• Research summary

  This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and erlotinib placebo once daily in patients with unresectable advanced or metastatic child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

• REC name

  West of Scotland REC 1

• REC reference

  09/S0703/72

• Date of REC Opinion

  3 Jun 2009

• REC opinion

  Further Information Favourable Opinion