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

Condition(s) studied

Investigational drug(s) / intervention(s)

Machine Learning-Based Risk Assessment: Point-of-care use of a locked machine learning-guided risk assessment tool with fixed thresholds and linked risk-stratified surveillance recommendations; no study-mandated treatment assignment is performed

Study 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

Primary outcome measure(s)

• Completion of a Prespecified Pathway-Concordant Action Within 60 Days — Day 0 to day 60 after the eligible index assessment.
  Proportion of eligible index episodes with completion of at least one prespecified pathway-concordant action within 60 days after the eligible index assessment. A pathway-concordant action was defined as SOP-concordant multidisciplinary team review, escalated lung- or bone-metastasis-directed imaging, or referral.

Trial sites (1)

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