Hepatic arterial infusion chemotherapy combined with camrelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma: A retrospective study.

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Background: PD-1 inhibitors combined with tyrosine kinase inhibitors have achieved encouraging efficacy in unresectable hepatocellular carcinoma (HCC). Hepatic arterial infusion chemotherapy (HAIC) with FOLFOX regimen has also shown promising response and survival benefits for advanced HCC. This study retrospectively analyzed the efficacy and safety of HAIC plus camrelizumab and lenvatinib in advanced HCC. Methods: Patients with advanced HCC who received ≥3 cycles of HAIC combined with camrelizumab and lenvatinib at Harbin Medical University Cancer Hospital from November 2020 to February 2023 were included. Baseline characteristics, treatment detail, tumor response, survival outcomes, and adverse events (AEs) were analyzed. Results: Sixty-four patients received HAIC plus camrelizumab and lenvatinib. Twenty-two (34.4%) were converted to resectable disease: 16 underwent hepatectomy, 1 received radiofrequency ablation, and 5 declined surgery. By mRECIST, 9 patients achieved complete response, 33 partial response, 16 stable disease, and 6 progressive disease, yielding an overall response rate (ORR) of 65.6%. By RECIST v1.1, the ORR was 59.4%. With a median follow-up of 47.8 months, median overall survival (OS) was not reacheds. The 1-, 2-, 3-, and 4-year OS rates were 87.2%, 70.4%, 60.2%, and 56.0%, respectively. Patients who underwent curative resection or ablation (n=17) had significantly longer OS than those without curative treatment (P<0.05). Median progression-free survival (PFS) for all patients was 19.3 months; 1-, 2-, 3-, and 4-year PFS rates were 69.0%, 34.4%, 20.7%, and 20.7%, respectively. For the 17 patients receiving curative treatment, median event-free survival (EFS) was not reached, with 1-, 2-, 3-, and 4-year EFS rates of 79.3%, 61.7%, 52.9%, and 52.9%, respectively. Patients achieving an objective response by mRECIST showed a trend toward improved OS (P=0.053). All patients experienced treatment-related AEs. Common AEs included constipation (98.4%), abdominal pain (98.4%), nausea (82.8%), hyperbilirubinemia (60.9%), elevated AST (69.4%), elevated ALT (57.8%), neutropenia (57.8%), leukopenia (51.6%), thrombocytopenia (46.9%), lymphopenia (43.8%), anemia (40.6%), increased γ-GT (39.1%), and hypothyroidism (10.9%). Grade 3-4 AEs included neutropenia (31.3%), lymphopenia (15.6%), hyperbilirubinemia (12.5%), elevated AST (7.8%), elevated γ-GT (7.8%), leukopenia (6.3%), elevated ALT (4.7%), thrombocytopenia (3.1%), anemia (1.6%), hypothyroidism (1.6%), and rash (1.6%). Conclusions: HAIC combined with camrelizumab and lenvatinib showed manageable toxicity and substantial antitumor activity in advanced HCC. The high response rate and 34.4% conversion to resectability suggest this triple regimen is a promising strategy for conversion therapy and long-term disease control.