Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial.

BMC Cancer 2019 Mar 28;19(1):275. Epub 2019 Mar 28.

Department of Radiation Oncology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, No. 2, Min-Sheng Road, Dalin, Chia-Yi, Taiwan, Republic of China.

Background: Hepatocellular carcinoma (HCC) accounts for 75-85% of primary liver cancers and is prevalent in the Asia-Pacific region. Till now, trans-arterial chemoembolization (TACE) is still one of common modalities in managing unresectable intermediate-stage HCC. However, post-TACE residual viable HCC is not uncommon, resulting in unsatisfied overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been suggested to manage HCC curatively. However, evidence from phase-III trials is largely lacking. Hence, the present phase III randomized trial is designed to compare clinical outcomes between SABR and re-TACE for unresectable HCC patients who had incomplete response after initial TACE.

Methods: The present study is an open-label, parallel, randomized controlled trial. A total of 120 patients will be included into two study groups, i.e., SABR and re-TACE, with a 1:1 allocation rate. A 3-year allocating period is planned. Patients with incomplete response after initial TACE will be enrolled and randomized. The primary endpoint is 1-year freedom-form-local-progression rate. Secondary endpoints are disease-progression-free survival, overall survival, local control, response rate, toxicity, and duration of response of the treated tumor.

Discussion: SABR has been reported as an effective modality in managing intermediate-stage HCC patients, but evidence from phase-III randomized trials is largely lacking. As a result, conducting randomized trials to demarcate the role of SABR in these patients is warranted, especially in the Asia-Pacific region, where HBV- and HCV-related HCCs are prevalent.

Trial Registration: Before enrolling participants, the present study was registered prospectively on ClinicalTrials.gov (trial identifier, NCT02921139 ) on Sep. 29, 2016. This study is ongoing.

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http://dx.doi.org/10.1186/s12885-019-5461-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6437913PMC
March 2019
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References

(Supplied by CrossRef)
Article in Gut and liver
RX Zhu et al.
Gut and liver 2016
Article in Medicine
IC Chang et al.
Medicine 2016
Article in Liver Cancer
M Kudo et al.
Liver Cancer 2016

KM McMasters et al.
2011
Article in J Am Coll Surg
C Cha et al.
J Am Coll Surg 2003
Article in The Cochrane database of systematic reviews
RS Oliveri et al.
The Cochrane database of systematic reviews 2011
Article in Hepatology
JM Llovet et al.
Hepatology 2003
Article in Gut
A Grieco et al.
Gut 2005
Article in J Radiat Res
Y Matsuo et al.
J Radiat Res 2016
Article in Int J Radiat Oncol Biol Phys
TS Su et al.
Int J Radiat Oncol Biol Phys 2017

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