Neoadjuvant Hepatic Arterial Infusion Chemotherapy with FOLFOX Plus Tislelizumab for Resectable Hepatocellular Carcinoma Beyond the Milan Criteria: Efficacy, Safety and Biomarker Exploration.

Authors

Quanwei Dai, Huiting Deng, Jun Wang, Jingxiang Shi, Jianmin Ding, Yanying Gao, Wei Sun, Yunzhi Shen, Ximo Wang, Cheng Lou

Published in

Journal of hepatocellular carcinoma. Volume 13. Pages 615120. Epub Aug 12, 2026.

Abstract

This study aimed to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, fluorouracil, and leucovorin (FOLFOX-HAIC) combined with tislelizumab as a neoadjuvant regimen in patients with resectable hepatocellular carcinoma (HCC) beyond the Milan criteria, and to explore predictive biomarkers of treatment response.
26 patients completed neoadjuvant therapy, with a median tumor size of 6.35cm. The objective response rate according to mRECIST criteria reached 57.7%, and the disease control rate was 96.2%. 22 patients underwent radical surgery, and 10 patients (10/22, 45.5%) achieved major pathological response (residual viable tumor ≤10%). Six patients (27.3%) achieved complete pathological response, and 25 patients (96.2%) experienced at least one treatment-related adverse events (TRAEs) The most common TRAEs were elevated transaminases (76.9%), HAIC-related pain (34.6%). Transcriptomic analysis revealed that differential genes between responding and non-responding tumors primarily involved pathways related to bile acid secretion and fatty acid metabolism. Metabolomic analysis showed elevated serum chenodeoxycholic acid (CDCA) in non-responders and elevated tumor glycocholic acid (GCA). Microbiome analysis further confirmed increased abundance of bile acid metabolism-related bacteria such as bacteroides in non-responders. Serum interleukin-6 (IL-6) levels after neoadjuvant therapy were correlated with treatment response.
FOLFOX-HAIC combined with tislelizumab as neoadjuvant therapy for HCC beyond the Milan criteria demonstrates favorable anti-tumor efficacy and controllable toxicity. The level of GCA in tumor, peripheral blood CDCA, IL-6, and fecal bacteroides may hold the potential to serve as a composite biomarker panel to predict pathological response and treatment sensitivity.

PMID:
42605348
Bibliographic data and abstract were imported from PubMed on 17 Aug 2026.

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