Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Face Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

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
    

Intervention name(s): TACE-Sorafenib group; TACE
Intervention type(s): Procedure; Procedure
Intervention description(s): Transcatheter arterial chemoembolization drugs and dosage:TACE with chemothrapy drugs (E-ADM 50mg, carboplatin 300 mg, MMC 8mg)and followed with embolization with lipiodol and absorbable gelatin sponge particles or polyvinyl alcohol particles.
Oral sorafenib (400 mg BID) will be start the 2-4 weeks after the first TACE treatment and will continue until the patient shows disease progression, until unacceptable toxicity occurs, or until study termination.
Other intervention name(s): TACE combined with Sorafenib
Intervention MeSH terms: Sorafenib; Chlorotrianisene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: TACE; Sorafenib; overall survival; time to progression