Abstract:
Objective To investigate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) with raltitrexed plus oxaliplatin (RALOX) combined with immune and targeted therapy in patients with intermediate and advanced hepatocellular carcinoma (HCC).
Methods We retrospectively enrolled 39 patients with intermediate and advanced HCC who received RALOX-HAIC combined with immune checkpoint inhibitors and targeted therapy from June 2020 to December 2021, in Nanfang Hospital, Southern Medical University. The initial HAIC treatment was used as the starting point. Disease progression, death, or unacceptable toxicity resulted in treatment discontinuation. The tumor response was evaluated using the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1), and patients were followed up until October 2022. The primary endpoint was the objective response rate (ORR). The secondary endpoints were disease control rate (DCR), median progression-free survival (mPFS), median overall survival (mOS), and safety.
Results The ORR and DCR were 41.0% and 87.2%, respectively. The mPFS was 7.3 months 95% confidence interval (CI): 5.0-9.6, and the mOS was 14.6 months (95%CI: 10.8-18.5). One patient underwent surgical resection and achieved complete response. The most common adverse events were fever, abdominal pain, bone marrow suppression, elevated aspartate aminotransferase levels, hypertension, and hand-foot skin reaction, with no treatment-related death reported.
Conclusions RALOX-HAIC combined with immune and targeted therapy was effective and safe in patients with intermediate and advanced HCC, laying a foundation for future prospective clinical research.