Entry Detail
| General information | |
| Database: | DB00892 |
| Objective: | Transarterial chemoembolization (TACE) is an important palliative treatment for unresectable hepatocellular carcinoma (hepatocellular carcinoma), but TACEinduced ischemic injury can upregulate angiogenic factors and is associated with poor prognosis. The aim of this study was to evaluate the safety and efficacy of concurrent conventional TACE and sorafenib in patients with unresectable hepatocellular carcinoma. |
| Authors: | Park JW, et al |
| Title: | Phase II study of concurrent transarterial chemoembolization and sorafenib in patients with unresectable hepatocellular carcinoma. |
| Journal: | J Hepatol. |
| Year: | 2012 |
| PMID: | 22314421 |
| Trial Design | |
| Clinical Trial Id: | NA |
| 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: | hepatocellular carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 16 |
| Therapeutic Combination Content: | transarterial chemoembolization + sorafenib |
| Study Type: | prospective, singlearm, phase II study |
| Key Patients Feature: | patients diagnosed with hepatocellular carcinoma at the NCC Hospital were enrolled and followed |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Sorafenib was given 3 days after TACE and was administered for up to 24 weeks. Repeated TACE was performed on demand. Tumor response was assessed every 8 weeks. |
| Primary End Point: | safety and time to progression (TTP). |
| Secondary End Point: | NA |
| Patients Number: | 50 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 40% |
| Disease Control Rate: | 84% |
| Median Time to Progression: | 7.1 months (95% confidence interval (CI), 4.87.5 months): 7.3 months in BCLC stage B; 5.0 months in BCLC stage C. |
| Median PFS A vs. C: | The 6month progression free survival rate was 52% (95% CI, 37.366.1). |
| Median OS A vs. C: | 20.8 months (95% CI, 18.6 monthsnot estimable). |
| Adverse Event(agent arm): | NA |
| Conclusions: | Concurrent treatment of unresectable hepatocellular carcinoma with conventional TACE and sorafenib demonstrates a manageable safety profile and a possibility of promising efficacy. |