Entry Detail
| General information | |
| Database: | DB00100 |
| Objective: | Assessing the efficacy and safety of new therapeutic options in an AsiaPacific population is important, where chronic hepatitis B infection is an important aetiological factor, this is to assess the efficacy and safety of sorafenib in patients from the AsiaPacific region with advanced (unresectable or metastatic)hepatocellular carcinoma |
| Authors: | Cheng AL, et al |
| Title: | Efficacy and safety of sorafenib in patients in the AsiaPacific region with advanced hepatocellular carcinoma: a phase III randomised, doubleblind, placebocontrolled trial. |
| Journal: | Lancet Oncol. |
| Year: | 2009 |
| PMID: | 19095497 |
| Trial Design | |
| Clinical Trial Id: | NCT00492752. |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | liver cancer |
| Cancer Subtype: | advanced hepatocellular carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a multinationalphase III, randomised, doubleblind, placebocontrolled trial |
| Key Patients Feature: | patients with hepatocellular carcinoma who had not received previous systemic therapy and had ChildPugh liver function class A, patients from 23 centres in China, South Korea, and Taiwan |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | placebo |
| Treatment Info: | pts were randomly assigned to receive either oral sorafenib (400 mg) or placebo twice daily in 6week cycles, with efficacy measured at the end of each 6week period. |
| Primary End Point: | overall survival, time to progression (TTP), time to symptomatic progression (TTSP), disease control rate (DCR), and safety were assessed. Efficacy analyses were done by intention to treat. |
| Secondary End Point: | NA |
| Patients Number: | 271 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | TTP:2.8 vs 1.4 (HR 0.57 [0.420.79]; p=0.0005). |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 6.5 vs 4.2[HR] 0.68 [95% CI 0.500.93]; p=0.014 |
| Adverse Event(agent arm): | The most frequently reported grade 3/4 drugrelated adverse events in the 149 assessable patients treated with sorafenib were handfoot skin reaction (HFSR; 16 patients [10.7%]), diarrhoea (nine patients [6.0%]), and fatigue (five patients [3.4%]). The most common adverse events resulting in dose reductions were HFSR (17 patients [11.4%]) and diarrhoea (11 patients [7.4%]); these adverse events rarely led to discontinuation. |
| Conclusions: | Sorafenib is effective for the treatment of advanced hepatocellular carcinoma in patients from the AsiaPacific region, and is well tolerated. Taken together with data from the Sorafenib Hepatocellular Carcinoma Assessment Randomised Protocol (SHARP) trial, sorafenib seems to be an appropriate option for the treatment of advanced hepatocellular carcinoma. |