ArticleJournal of hepatocellular carcinoma2026
Fatty Acid Degradation (FAD) Subtype-Informed Treatment Allocation in Unresectable Hepatocellular Carcinoma (FAD-HCC-01): Protocol for a Prospective Multicentre Proof-of-Concept Study.
Article in Journal of hepatocellular carcinoma, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Hepatocellular carcinoma (HCC) exhibits substantial biological and metabolic heterogeneity, contributing to variable therapeutic responses in unresectable disease. Although immune checkpoint inhibitors combined with anti-angiogenic agents have improved outcomes, treatment selection remains largely empirical because validated predictive biomarkers are lacking. Recent multi-omics studies have identified fatty acid degradation (FAD)-related transcriptional signatures that classify HCC into distinct metabolic subtypes with different immune microenvironment characteristics and therapeutic vulnerabilities. Retrospective analyses suggest that F1/F2 subtypes may derive greater benefit from immune checkpoint inhibitor-based systemic therapy, whereas F3 tumours may be more responsive to transarterial chemoembolisation (TACE). However, whether FAD-based metabolic stratification can prospectively inform treatment allocation remains unknown. Methods: FAD-HCC-01 is a prospective, multicentre, open-label proof-of-concept Phase II study designed to evaluate the feasibility and preliminary clinical activity of FAD-informed treatment allocation in patients with unresectable HCC. Eligible patients with Barcelona Clinic Liver Cancer stage B or C disease and no prior systemic therapy will undergo baseline tumour transcriptomic profiling to determine FAD subtype. Patients with F1/F2 tumours will receive camrelizumab plus rivoceranib, whereas patients with F3 tumours will receive TACE combined with camrelizumab and rivoceranib. Eighty-six patients will be enrolled, with 43 in each biomarker-defined cohort. The primary endpoint is objective response rate according to RECIST version 1.1. Secondary endpoints include objective response rate by mRECIST, disease control rate, progression-free survival, overall survival, duration of response, conversion to curative treatment, and safety. Exploratory analyses will assess concordance between MRI-derived proton density fat fraction and transcriptomic FAD classification. Conclusion: This proof-of-concept study will prospectively assess whether FAD-based metabolic subtyping can inform treatment allocation in unresectable HCC. The results may provide early evidence supporting metabolism-informed precision therapy and the design of future biomarker-guided clinical trials.
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