Abstract
BackgroundHepatocellular carcinoma is a primary malignant tumor of the liver that accounts for an important health problem worldwide. Only 10 to 15% of hepatocellular carcinoma patients are suitable candidates for treatment with curative intent, such as hepatic resection and liver transplantation. A majority of patients have locally advanced, liver restricted disease (Barcelona Clinic Liver Cancer (BCLC) staging system intermediate stage). Transarterial loco regional treatment modalities offer palliative treatment options for these patients; transarterial chemoembolization (TACE) is the current standard treatment. During TACE, a catheter is advanced into the branches of the hepatic artery supplying the tumor, and a combination of embolic material and chemotherapeutics is delivered through the catheter directly into the tumor. Yttrium-90 radioembolization (90Y-RE) involves the transarterial administration of minimally embolic microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor. 90Y-RE is increasingly used in clinical practice for treatment of intermediate stage hepatocellular carcinoma, but its efficacy has never been prospectively compared to that of the standard treatment (TACE). In this study, we describe the protocol of a multicenter randomized controlled trial aimed at comparing the effectiveness of TACE and 90Y-RE for treatment of patients with unresectable (BCLC intermediate stage) hepatocellular carcinoma.Methods/designIn this pragmatic randomized controlled trial, 140 patients with unresectable (BCLC intermediate stage) hepatocellular carcinoma, with Eastern Cooperative Oncology Group performance status 0 to 1 and Child-Pugh A to B will be randomly assigned to either 90Y-RE or TACE with drug eluting beads. Patients assigned to 90Y-RE will first receive a diagnostic angiography, followed by the actual transarterial treatment, which can be divided into two sessions in case of bilobar disease. Patients assigned to TACE will receive a maximum of three consecutive transarterial treatment sessions. Patients will undergo structural follow-up for a timeframe of two years post treatment. Post procedural magnetic resonance imaging (MRI) will be performed at one and three months post trial entry and at three-monthly intervals thereafter for two years to assess tumor response. Primary outcome will be time to progression. Secondary outcomes will be overall survival, tumor response according to the modified RECIST criteria, toxicities/adverse events, treatment related effect on total liver function, quality of life, treatment-related costs and cost-effectiveness.Trial registrationNCT01381211
Highlights
Hepatocellular carcinoma is a primary malignant tumor of the liver that accounts for an important health problem worldwide
10% to 15% of all patients with Hepatocellular carcinoma (HCC) are eligible for treatment with curative intent, and local ablative treatment is limited by strict criteria on the stage of the disease (that is, disease confined to the liver and limited number of lesions with relatively small dimensions according to the Barcelona Clinic Liver Cancer (BCLC) staging classification)
This anatomical fact provides the basis for the development of intra-arterial therapies for the treatment of HCC, with the potential of selectively inducing tumor necrosis while sparing surrounding liver parenchyma. Antitumoral agents, such as cytotoxic drugs or radionuclides, can be delivered at the site of the tumor, as they lodge in the peritumoral vascular bed after intra-arterial injection. This randomized controlled trial is designed to compare two transarterial loco regional therapies applied for the treatment of patients with intermediate stage HCC: transarterial chemoembolization (TACE), the current standard treatment, and Yttrium-90 radioembolization (90Y-RE), a newer treatment modality
Summary
Hepatocellular carcinoma (HCC), a primary malignant tumor of the liver, is the sixth most common cancer worldwide with an incidence of 626,000 new patients a year, and the third most common cause of cancerrelated death [1]. Antitumoral agents, such as cytotoxic drugs or radionuclides, can be delivered at the site of the tumor, as they lodge in the peritumoral vascular bed after intra-arterial injection This randomized controlled trial is designed to compare two transarterial loco regional therapies applied for the treatment of patients with intermediate stage HCC: transarterial chemoembolization (TACE), the current standard treatment, and Yttrium-90 radioembolization (90Y-RE), a newer treatment modality. Subgroup analysis showed that TACE-DEB results in a higher tumor control rate in patients with Child-Pugh B cirrhosis, bilobar disease or reduced performance score compared to conventional TACE. This was achieved without an increased risk of adverse events [15]. This randomized controlled trial is designed to prospectively compare TACE and 90Y-RE for treatment of patients with unresectable (BCLC intermediate stage) HCC
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