Sorafenib plus hepatic arterial infusion chemotherapy versus sorafenib plus transarterial chemoembolization in advanced hepatocellular carcinoma: a phase III trial and biomarker analyses
In brief
Sorafenib plus hepatic infusion lifts median survival to 16 months, vs 11
In a phase III trial of 207 patients with advanced liver cancer, adding hepatic arterial infusion chemotherapy to sorafenib extended median overall survival to 15.7 months compared with 11.2 months for sorafenib plus chemoembolization, and also doubled progression-free survival while causing fewer grade 3-4 side effects. Higher tumor PFKM levels appeared to favor the chemoembolization approach, suggesting a potential biomarker-guided choice.
- Journal
- Journal of the National Cancer Center (Q1)
- Published
- 19 May 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Zhicheng Lai, Zefeng Du, Lichang Huang, Qijiong Li, Yexing Huang, Li Xu, et al.
- PMID
- 42630515
- DOI
- 10.1016/j.jncc.2026.04.002
Why clinicians should know about it
- Picked for Oncology and Radiation Oncology (top studies of the week, 23 August 2026): SoraHAIC significantly improves OS over SoraTACE
Abstract
OBJECTIVE: Although sorafenib plus transcatheter arterial chemoembolization (SoraTACE) has been widely applied for advanced hepatocellular carcinoma (HCC) in most Asian countries, sorafenib plus hepatic arterial infusion chemotherapy (SoraHAIC) may be a better alternative. This phase III trial assessed the efficacy and safety of SoraHAIC versus SoraTACE in patients with advanced HCC. METHODS: Participants were randomly assigned (2:1) to receive SoraHAIC (400 mg of sorafenib twice daily plus FOLFOX-HAIC every 3 weeks) or SoraTACE (400 mg of sorafenib plus TACE). The primary endpoint was overall survival (OS). RESULTS: From August 2016 to October 2020, 207 participants were allocated to receive SoraHAIC (n = 141) or SoraTACE (n = 66). SoraHAIC significantly improved OS (median OS, 15.7 vs. 11.2 months; hazard ratio [HR], 0.58 [95% CI: 0.42, 0.80]; P < 0.001) and progression-free survival (median, 7.2 vs. 4.1 months; HR, 0.48 [95% CI: 0.35, 0.65]; P < 0.001) compared to SoraTACE. The incidence of grade 3-4 treatment-related adverse events was significantly lower with SoraHAIC (39.3%) than SoraTACE (56.7%) (P < 0.023). Biomarker exploration indicated that patients with higher phosphofructokinase (PFKM) expression benefitted more from SoraTACE. CONCLUSIONS: SoraHAIC significantly improves OS over SoraTACE in participants with advanced HCC. Participants with high PFKM expression might benefit more from SoraTACE.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.