Spots Global Cancer Trial Database for Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma

Study Description

Brief Summary: Hepatocellular carcinoma (HCC) is the 6th most common cancer and the third most frequent cause of cancer death worldwide. Hepatic resection (HR) has been the standard treatment modality for HCC aiming at clinical cure. In both Europe and Unit States proposed guidelines for HCC, HR was recommend only for patients with a single HCC lesion and preserved liver function . Unfortunately, only 10%-30% of HCCs are amenable to such "curative" surgical resection at the time of diagnosis, because of tumor multifocality, portal vein invasion, and underlying advanced liver cirrhosis . Alternatively, transarterial chemoembolization (TACE) has become the most popular modality for palliative treatment for the other patients. However, the long term outcomes were generally poor for HCC patients treated with TACE. Recently, sorafenib has shown some promises in improvement of 3-month survival among patients with advanced HCC. It is claimed that sorafenib has become the standard of care for patients advanced HCC. Thus, the purpose of this study was to prospectively compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC .

Detailed Description: Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC. Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo. It is interesting to recognize the combined therapeutic effect of TACE with sorafenib. The proposed study will make an important contribution to understanding not only the safety and efficacy of sorafenib in addition to TACE in patients diagnosed with unresectable HCC, but this will also be the first clinical trial prospectively to compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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