Prospective Evaluation of a Locked Risk-Stratified Surveillance Strategy for Extrahepatic Metastasis in Hepatocellular Carcinoma

Location: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Summary

This is a multicenter prospective observational cohort study in adults with hepatocellular carcinoma (HCC) without baseline extrahepatic metastasis who are receiving routine clinical management and follow-up at participating centers. The study evaluates the real-world implementation and clinical utility of a locked machine learning-guided risk stratification strategy for predicting lung and bone metastasis and supporting risk-stratified surveillance. The locked strategy uses prespecified 12-month risk thresholds and linked care pathways and is implemented without retraining or threshold revision. No study-mandated treatment or surveillance assignment is performed; clinical care remains at physician discretion according to local practice. The study assesses model transportability and calibration, implementation outcomes (including completion of prespecified actions, timeliness of action, and treatment activation), clinically actionable detection outcomes, patient-important outcomes, and longer-term survival. Comparative analyses use centre- and calendar-epoch-aligned usual-care episodes as the primary observational comparator.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years. * Diagnosis of hepatocellular carcinoma (HCC) confirmed by histopathology or accepted radiologic criteria per international guidelines. * No evidence of extrahepatic metastasis at baseline evaluation. * Receiving standard-of-care management with planned longitudinal follow-up in routine clinical practice. * Availability of baseline clinical and imaging data required for risk assessment using the pre-specified machine learning model. * Ability to provide written informed consent, or inclusion under ethics committee-approved procedures. Exclusion Criteria: * Confirmed extrahepatic metastasis at enrollment (baseline). * History of other active malignancy within the past 5 years, except adequately treated non-melanoma skin cancer or in situ carcinoma. * Incomplete baseline clinical information that precludes model-based risk assessment. * Expected survival \< 3 months due to severe comorbidities. * Participation in an interventional clinical trial that may substantially alter follow-up strategy or metastasis assessment.

Source: ClinicalTrials.gov (NCT07444905). StuddyBuddy aggregates publicly available trial information.