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Chinese Journal of Hepatic Surgery(Electronic Edition) ›› 2025, Vol. 14 ›› Issue (02): 225-231. doi: 10.3877/cma.j.issn.2095-3232.2025041

• Clinical Researches • Previous Articles     Next Articles

Hepatic arterial infusion chemotherapy(HAIC) combined with lenvatinib plus PD-1 inhibitor versus HAIC combined with lenvatinib for unresectable hepatocellular carcinoma

Shitao Zeng1, Qing Yan2, Shan Liao2, Huanwei Chen1,2,()   

  1. 1. The First Clinical College of Guangdong Medical University,Zhanjiang 524023,China
    2. Department of Hepatobiliary and Pancreatic Surgery,the First People’s Hospital of Foshan,Foshan 528010,China
  • Received:2024-12-10 Online:2025-04-10 Published:2025-03-28
  • Contact: Huanwei Chen

Abstract:

Objective

To compare clinical efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib plus PD-1 inhibitor and HAIC combined with lenvatinib in the treatment of unresectable hepatocellular carcinoma (HCC).

Methods

Clinical data of 84 patients diagnosed with unresectable HCC by pathological biopsy or imaging examination in the First People’s Hospital of Foshan from April 2020 to December 2023 were analyzed retrospectively.The informed consents of all patients were obtained and the local ethical committee approval was received.Among them,76 patients were male and 8 female, aged from 32 to 75 years, with a median age of 54 years.According to different treatment methods, 48 patients received HAIC combined with lenvatinib plus PD-1 inhibitor(triple group), and 36 cases were treated with HAIC combined with lenvatinib (double group).HAIC was given using modified FOLFOX6 regimen.The progression-free survival (PFS), overall survival (OS),objective remission rate (ORR), disease control rate (DCR) and treatment-related adverse events were compared between two groups.The rate comparison between two groups was conducted by Chi-square test or Fisher’s exact probability test.Survival analysis was performed by Kaplan-Meier method and Log-rank test.

Results

Survival analysis showed that the median PFS in the triple group was 10.6 months, significantly longer than 5.2 months in the double group (χ2=9.30, P<0.05).However, the ORR and DCR in the triple group were 70.8%(34/48) and 93.8%(45/48), and 66.7%(24/36) and 86.1%(31/36) in the double group, with no statistical significance between two groups (χ2=0.167,-; both P>0.05).The incidence of adverse reactions in the triple and double groups were 96%(46/48) and 89%(32/36), with no statistical significance between two groups (P>0.05).5 patients in each group underwent conversion surgery.Postoperative pathological examination indicated that 4 patients in the triple group achieved pathologic complete response (pCR), and 1 patient in the double group achieved pCR.Multivariate Cox regression analysis showed that compared with triple therapy, double therapy was an independent risk factor of PFS (HR=1.924, 95%CI: 1.150-3.220,P<0.05).

Conclusions

The triple therapy of HAIC combined with lenvatinib plus PD-1 inhibitor is superior to HAIC combined with lenvatinib in delaying tumor progression, and triple therapy may yield a higher tumor necrosis rate.However, two regimens are equivalent in terms of ORR and DCR.

Key words: Carcinoma, hepatocellular, Hepatic arterial infusion chemotherapy, Lenvatinib, PD-1 inhibitor, Progression free survival, Treatment related adverse event (TRAE)

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