Combined treatment of hepatocellular carcinoma using thermal ablation and a new balloon catheter device: the Season-HCC trial.

BACKGROUNDS Hepatocellular carcinoma (HCC) is ranked among the most prevalent causes of cancer fatalities across the world. Despite the availability of numerous effective treatments, the mortality is on the rise, posing a significant impact on the healthcare systems. In some specific settings (HCC sizing and number of lesions), the balloon-occluded method using the Occlusafe™ microballoon has been advocated to enhance the complete response and minimize complications. Furthermore, this technique has demonstrated promising results in the therapeutic pathway of HCC when synergized with other loco-regional treatments such as thermal ablation and drug-eluting beads transarterial chemoembolization (DEB-TACE). The study aims to assess the safety and effectiveness of single-step combined therapy in patients with intermediate-sized HCC (3-5 cm) in terms of balloon-occluded MWA (B-MWA) plus transcatheter arterial balloon-occluded chemoembolization (B-TACE) and compare the therapeutic efficacy of different methods to determine the optimal approach. MATERIALS AND METHODS This is a multicenter randomized, controlled, open-label trial (the Season-HCC trial). The study involves the enrolment of 12 patients (per center) with at least one HCC nodule measuring between 3-5 cm who are excluded from surgical resection. The selected patients will be randomly assigned to one of three treatment arms: Arm 1: Occlusafe-assisted MWA in combination with DEB-TACE; Arm 2: Occlusafe-assisted MWA alone; and Arm 3: MWA combined with DEB-TACE. Four weeks prior to the treatment, all patients will undergo a screening visit to assess the feasibility of percutaneous treatment at Azienda Ospedaliera Città della Salute e della Scienza di Torino. The treatments will be performed using a single-step approach: performing B-MWA of the lesion using a balloon of the hepatic artery supplying the tumor, followed by B-TACE techniques. Afterwards, patients will undergo a follow-up schedule: the complications will be assessed with the CIRSE classification, and serial CT reassessment will be conducted to evaluate effectiveness through mRECIST criteria over 13 months. RESULT Patients enrollment is ongoing at “Azienda Ospedaliera Citta` della Salute e della Scienza” of Torino. Three out of 12 patients selected for the study were included, with 2 allocated to arm 1 and 1 to arm 3. Technical success was achieved in all procedures, and no significant complications were encountered. The new cases and follow-up data will be updated over the next three years. CONCLUSION The Season-HCC protocol ultimately emphasizes several of the most recent rationales behind the combined single-step approach of the balloon-occluded technique, TACE, and thermal ablation in non-surgical treatment of intermediate-sized HCC. Our preliminary data demonstrate that the Occlusafe microballoon, as an adjunctive tool in liver embolization, allows for redistribution of blood flow into the tumor and also enhances effectiveness when combined with other loco-regional treatment techniques, thereby increasing the chances of achieving a complete response.