| Official Title |
A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation |
| Countries |
Global |
| Clinical Phase |
Phase III |
| Study Arm |
Arm 1: Sorafenib
Arm 2: Placebo |
| Description |
Hepatocellular Carcinoma (HCC) is the 5th most common cancer worldwide. Surgery/local ablation to remove/ablate the tumor remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery/local ablation is common and survival after recurrence is poor. Currently there is no recommended standard adjuvant treatment for HCC immediately after surgical resection/local ablation that has been shown to reduce recurrence. Sorafenib is a new anticancer drug which blocks the growth of new blood vessels in tumors. Sorafenib is approved for treatment of advanced HCC.
The purpose of this study is to determine if Sorafenib is effective and safe as an adjuvant therapy in patients who had surgery/local ablation for HCC. |
| Age Eligible for study |
18 years and older |
| Genders Eligible for Study |
Both |
| Key Inclusion Criteria |
- Histologically-proven primary hepatocellular carcinoma with curative resection performed in the 4-6 weeks prior to randomization
- ECOG performance status 0
- Child Pugh classification A
|
| Key Exclusion Criteria |
- Any evidence of tumor metastasis or co-existing malignant disease
- Any prior recurrence of HCC or any liver resection/local ablation prior to the most recent procedure
- History of prior HCC therapy
|
