A prospective study of radiofrequency ablation combined with systematic neoadjuvant therapy in the treatment of recurrent hepatocellular carcinoma (RANT study).

Abstract

e16240 Background: Radiofrequency ablation (RFA) is an important minimally invasive approach for recurrent HCC, but is hampered by the high recurrence rate and limited ablation volume for the tumor. This study aims to evaluate the efficacy and safety of systemic neoadjuvant therapy (tislelizumab combined with lenvatinib/bevacizumab) combined with RFA in the treatment of recurrent HCC. Methods: This prospective, single-arm, phase II trial enrolled patients with recurrent resectable HCC who has a history of liver resection or RFA (the number of lesions ≤ 3, the largest lesion ≤ 3 cm, as demonstrated by contrast enhanced CT/MRI). Prior to RFA, patients received tislelizumab (200 mg, q3w, iv) and lenvatinib (body weight≥60 kg, 12 mg; <60 kg, 8 mg, qd, po) or bevacizumab (15mg/kg) for two cycles. RFA was scheduled in one week after the systemic neoadjuvant therapy. After 4-8 weeks of surgery, patients continued to receive tislelizumab and lenvatinib /bevacizumab for 6 to 12 months. Primary endpoint was one-year relapse-free survival (RFS) rate and one-year overall survival (OS) rate. Secondary endpoints were objective response rate (ORR) by mRECIST, and adverse events (AE). Results: From November 2021 to October 2023, 20 patients (median age, 57 years) were enrolled, all Child-Pugh A and ECOG PS 0, mostly males (95%) and HBV infection (90.0%). 19 patients had received 2 cycles systemic neoadjuvant therapy and RFA was successfully performed, 1 patient achieved complete response after systemic treatment and didn't perform RFA. According to mRECIST, the ORR was 50% (95%CI: 27.20%-72.80%), and the DCR was 100 % (CR 1, PR 8, SD 11). After a median follow-up of 8.5 months (interquartile range 5-21 months), tumor recurrence was detected in 2 patients, 1 patient died of disease recurrence. The estimated 12-month RFS rate and OS rate were 76.9% (95%CI 31.2%, 94.3%) and 100%, respectively. Median RFS and OS were not reached. So far the safety of neoadjuvant treatment was satisfied, no grade 4 or above treatment-related-adverse events (TRAEs) were observed. Grade 3 TRAEs were reported in 3(13.04%) patients. Frequently occurring adverse eventswere grade 1-2, including total bilirubin increased (39.13%), elevated aspartate aminotransferase (30.43%), and elevated alanine aminotransferase (30.43%). Conclusions: Radiofrequency ablation combined with systematic neoadjuvant therapy exhibited promising efficacy and favorable safety for recurrent HCC. Clinical trial information: NCT05277675 .