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

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.

NCT Number	NCT07444905
Lead Sponsor	Tongji Hospital
Conditions	HCC - Hepatocellular Carcinoma, Machine Learning, Evaluation
Enrollment	1,523 participants
Start Date	2022-02-01
Primary Completion	2026-12-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-03