Prospective, randomized, double-blind, multi-center, Phase III clinical study on transarterial chemoembolization (TACE) combined with Sorafenib® versus TACE plus placebo in patients with hepatocellular cancer before liver transplantation – HeiLivCa [ISRCTN24081794]
2008

Study on TACE and Sorafenib for Liver Cancer Before Transplant

Sample size: 208 publication Evidence: moderate

Author Information

Author(s): Katrin Hoffmann, Hanno Glimm, Boris Radeleff, Goetz Richter, Christoph Heining, Irini Schenkel, Anita Zahlten-Hinguranage, Peter Schirrmacher, Jan Schmidt, Markus Büchler, Dirk Jaeger, Christof Kalle, Peter Schemmer

Primary Institution: Ruprecht-Karls-University, Heidelberg, Germany

Hypothesis

Does combining transarterial chemoembolization (TACE) with Sorafenib improve outcomes for patients with hepatocellular cancer before liver transplantation compared to TACE plus placebo?

Conclusion

The study aims to determine if TACE combined with Sorafenib is more effective than TACE alone in treating hepatocellular cancer before liver transplantation.

Supporting Evidence

  • Hepatocellular carcinoma is a leading cause of cancer death worldwide.
  • TACE is the standard treatment for patients with hepatocellular carcinoma awaiting liver transplantation.
  • Sorafenib has been shown to improve survival in patients with advanced hepatocellular carcinoma.

Takeaway

This study is testing if a cancer treatment called TACE works better when combined with a pill called Sorafenib for patients waiting for a liver transplant.

Methodology

The study is a double-blinded, controlled, prospective, randomized multi-centre phase III trial comparing TACE plus Sorafenib to TACE plus placebo.

Potential Biases

Potential biases may arise from the randomization process and patient selection criteria.

Limitations

The study may have a high drop-out rate, and results may not be generalizable to all patients with hepatocellular carcinoma.

Participant Demographics

Patients over 18 years of age with histologically confirmed hepatocellular carcinoma, without extrahepatic disease.

Digital Object Identifier (DOI)

10.1186/1471-2407-8-349

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