Abstract
BackgroundHepatocellular 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.MethodsThe 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.DiscussionSABR 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 registrationBefore enrolling participants, the present study was registered prospectively on ClinicalTrials.gov (trial identifier, NCT02921139) on Sep. 29, 2016. This study is ongoing.
Highlights
Hepatocellular carcinoma (HCC) accounts for 75–85% of primary liver cancers and is prevalent in the Asia-Pacific region
Hypothesis We hypothesize that stereotactic ablative radiotherapy (SABR) is able to demonstrate better clinical outcomes than that of re-trans-arterial chemoembolization (TACE) for HCC patients who have incomplete response after their initial TACE, in terms of tumor response, local-progression-free and patient survival
Several tumor responses will be defined by two independent physicians: complete response (CR), total disappearance; partial response (PR), 30% decrease in single longest diameter (SLD) of contrast-enhanced part; stable disease (SD), neither partial response nor progressive disease met; and, progressive disease (PD), 20% increase of SLD or new lesion(s)
Summary
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. 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
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