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

Abstract

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.

Current State of Liver-Directed Therapies and Combinatory Approaches with Systemic Therapy in Hepatocellular Carcinoma (HCC)

“…Despite the increase in interest and utilization of SBRT in HCC, there is general a lack of randomized trials. A phase III trial (planned n = 120) is investigating the role of SBRT against repeated TACE in HCC patients with incomplete response to previous TACE sessions (NCT02921139) [26].…”

Clinical Effect of Iodine-125 Seed Implantation in Patients with Primary Liver Cancer and Its Effect on Th1/Th2 Cells in Peripheral Blood

“…Chemotherapy is the preferred treatment for patients with primary liver cancer; transarterial chemoembolization (TACE) is the main treatment [ 17 , 18 ]. High concentration of chemotherapeutic drugs can be injected into the tumor lesions, and then the tumor supplying blood vessels can be embolized through an embolization agent, which can make the tumor inactivated under the dual effects of ischemia and hypoxia.…”

Stereotactic Body Radiation Therapy vs. Transarterial Chemoembolization in Inoperable Barcelona Clinic Liver Cancer Stage a Hepatocellular Carcinoma: A Retrospective, Propensity-Matched Analysis

“…Additional multi-institutional prospective studies are warranted for the investigation of the real effects of SBRT. The TASABR randomized controlled trial is underway and will compare SBRT vs. re-TACE for HCC patients who had an incomplete response after initial TACE (39). A randomized phase 2 trial (NCT02182687), designed to compare TACE or SBRT as a bridge to transplant with the primary outcome as time to first additional intervention, is underway.…”