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Vascular Invasion Prediction Via a Multimodal Model Supports Re-staging of Early-stage Hepatocellular Carcinoma
Sponsor: Eastern Hepatobiliary Surgery Hospital
Summary
Effective strategies for personalized treatment decisions for early-stage hepatocellular carcinoma (HCC) remain critically limited. Microvascular invasion (MVI) is a distinctive pathological hallmark of HCC invasiveness. Current evidence underscores that accurate preoperative prediction of MVI has the potential to support personalized selection among surgical resection, liver transplantation, and local ablation, as well as different approaches within each modality. However, despite numerous studies on MVI prediction, accuracy remains insufficient. Currently, radiomics and liquid biopsy are at the forefront of MVI prediction. Furthermore, combining both technologies may offer a more reliable prediction, but this integrated approach remains unexplored. This large-scale prospective cohort study (an observational study design). aims to develop a multimodal approach to predict MVI by integrating four data sources: clinicopathological variables, MRI-based radiomics features, MRI-based deep learning features, and MVI-related genomic alterations detected in circulating cell-free DNA (cfDNA). Individual models will first be developed for each data modality. Their predictive outputs will be calibrated into standardized risk probabilities and integrated via decision-level fusion to generate the final multimodal model. This system will be used to preoperatively stratify patients by predicted MVI risks. Based on this risk stratification, a re-staging system for early-stage HCC will be developed. Its prognostic value and clinical utility will be evaluated, with its ability to guide the selection of optimal resection margins to improve outcomes as a key illustrative example. The primary endpoints are 5-year recurrence-free survival (RFS), 5-year overall survival (OS), and recurrence patterns.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
3650
Start Date
2022-01-01
Completion Date
2026-04-30
Last Updated
2026-09-28
Healthy Volunteers
No
Interventions
Curative-intent liver resection
All patients have undergone curative-intent resection for early-stage HCC. A wide resection margin is defined as ≥1 cm, and a narrow margin as \<1 cm. The prognostic comparison of wide resection margin versus narrow margin will be conducted among patients who were technically eligible for either approach, as determined by clinical guidelines and the assessment of an independent panel of surgical specialists.
Locations (1)
Eastern Hepatobiliary Surgery Hospital, Naval Medical University,
Shanghai, Shanghai Municipality, China