Hepatic Artery Infusion Chemotherapy (HAIC) Plus Durvalumab for Advanced Hepatocellular Carcinoma

Summary

Hepatic artery infusion chemotherapy (HAIC) and anti-programmed cell death protein-1ligand (PD-L1) immunotherapy have shown promising outcomes in patients with advanced hepatocellular carcinoma (HCC), respectively. However, the combination of the two treatments has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy and safety in patients with advanced hepatocellular carcinoma (Ad-HCC) with portal vein embolism who are undergoing hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment combined with anti-PD-L1 immunotherapy (Durvalumab) by designing an open, single-arm phase II clinical study.

Timeline

Start

2022-04-11

Primary completion

2024-07-05

Completion

2024-07-05

Outcome

Met primary endpoint

paper The pre-specified study endpoints were achieved, the 1-year OS rate was 63.3% PMID 42151180 ↗

Publications

• Background Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.
• Background Lyu N, Lin Y, Kong Y, Zhang Z, Liu L, Zheng L, Mu L, Wang J, Li X, Pan T, Xie Q, Liu Y, Lin A, Wu P, Zhao M. FOXAI: a phase II trial evaluating the efficacy and safety of hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin for advanced hepatocellular carcinoma. Gut. 2018 Feb;67(2):395-396. doi: 10.1136/gutjnl-2017-314138. Epub 2017 Jun 7. No abstract available.
• Yi J, Wang J, Zhang Y, Jiang X, Chen S, Xu J, Wu X, Zhong S, Chen Q, Hu Y, Song Y, Tan G, Zhang Y, Li J, Zhao M, Lyu N. Durvalumab plus HAIC-FOLFOX followed by maintenance durvalumab for hepatocellular carcinoma with major portal invasion: phase 2 DurHope study. Nat Commun. 2026 May 18. doi: 10.1038/s41467-026-73131-y. Online ahead of print.

Drugs

Indications