Sintilimab plus lenvatinib in combination with transarterial chemoembolization and subsequent radiofrequency ablation for unresectable hepatocellular carcinoma: a single-arm, single-center study

This study was designed to assess the safety and efficacy of Sintilimab plus Lenvatinib in combination with transarterial chemoembolization (TACE) and subsequent radiofrequency ablation (RFA) in the treatment of unresectable hepatocellular carcinoma (HCC). A retrospective data analysis was conducted on 21 patients diagnosed with HCC at Yibin First People's Hospital, between February 2021 and July 2022. These patients met the eligibility criteria and underwent TACE followed by RFA. After the first TACE, patients received maintenance therapy with Sintilimab and Lenvatinib until the occurrence of intolerable toxicity, disease progression, or demise. The primary endpoints were progression-free survival (PFS) and overall survival (OS). The efficacy evaluation revealed a complete response (CR) in 7 patients (33.33%), a partial response (PR) in 13 (61.91%), and a stable disease (SD) in 1 (4.76%). The patients had a median follow-up duration of 29.4 months (95% CI, 24.67-34.14), with a median PFS of 17.3 months (95% CI, 5.84-28.76). The median OS was not reached (NR), with a 1-year OS rate of 95.24% and a 2-year OS rate of 75.89%. Tumor recurrence and metastasis occurred in 15 patients (71.43%), oligoprogression in 8 patients (38.90%) and extensive progression in 7 patients (33.33%), which were associated with the median OS duration of NR and 26.03 months (95%CI 17.48-34.59), respectively (P = 0.024). In terms of treatment safety, 95.24% (20 cases) of patients experienced treatment-related adverse events (AEs), mainly mild to moderate severity. Notably, 10 patients (47.62%) encountered at least one grade 3 or higher AEs, leading to treatment discontinuation in 2 patients due to severe side effects. The clinical efficacy and safety of Sintilimab plus Lenvatinib in combination with TACE followed by RFA has been shown to be promising in the treatment of unresectable HCC. These results suggested that this combined treatment strategy may be an effective therapeutic approach. Furthermore, patients with oligoprogression after initial treatment exhibited a more favorable prognosis, indicating a need for further exploration and validation by studies with larger sample sizes.