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Monday, February 18, 2019

Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial

Clinical question
Does combination therapy of Sorafenib with cTACE increase overall survival for patient with advanced hepatocellular carcinoma?

Take-away point
In this phase III prospective appropriately powered clinical trial, there was no improvement in overall survival by combining TACE with Sorafenib in advanced HCC.

Park, Joong-Won, et al. Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial. Journal of Hepatology. December, 2018. In Press.

Click here for abstract

Study design: Prospective Randomized Control Trial

Funding source: National Cancer Center, Korea.

Setting: Multihospital – across South Korea.


This is a prospective phase III randomized controlled clinical trial to evaluate the primary endpoint of overall survival (OS) in advanced HCC patients receiving either sorafenib alone or in combination with cTACE. The study was powered to detect no change. The authors found no improvement in OS with concurrent therapy (median survival 12.8 months) vs monotherapy with sorafenib alone (median survival 10.8 months). There was significant improvement in secondary outcomes, including time to progression, progression free survival, and tumor response rates, in those patients receiving combination therapy. The authors also noted in post-hoc analysis that patients who were only able to receive one cTACE session did especially worse (decreased OS), attributed to the significant increase in adverse events seen with combination therapy. Contrary to this, there was a suggestion of improved survival in those patients who underwent at least two cTACE sessions.


This is a well-designed prospective study that sheds light on the use of multimodality therapy in advanced HCC. It should be noted that this study was performed in Korea, where hepatitis B virus (75%) was the dominant etiology with 68% of patients having cirrhosis. In addition, advanced HCC was defined by the modified Union for International Cancer Control (mUICC) staging system, that, while similar to BCLC, is slightly different in its definition of advanced HCC. The majority of the included patients had also undergone prior interventions for HCC, including 72% having previously undergone TACE.

The authors note the limitations of this study including the pre-supposed survival times not matching the observed survival times, potentially affecting the power of the study. They also note that while subject to bias, there was some observed improvement in survival for combination therapy in patients who were able to tolerate multiple sessions of cTACE. This may warrant additional evaluation, as patients who tolerate the side effect profile and can undergo multiple locoregional therapies may see some benefit from this dual therapy approach.

Post Author:
Daniel P. Sheeran, MD
Assistant Professor
Department of Radiology and Medical Imaging
Division of Vascular and Interventional Radiology
University of Virginia

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