Hepatocellular carcinoma, the most common type of primary liver cancer, can recur after liver resection or thermal ablation performed with curative intent. Follow-up imaging is commonly scheduled at fixed intervals, although the risk of recurrence differs among patients and may change over time. This study will test whether a locked artificial intelligence system can use routinely collected clinical, laboratory, and imaging information to recommend when the next surveillance scan should occur.
Adults with no radiological evidence of viable hepatocellular carcinoma after microscopically margin-negative liver resection or complete radiofrequency or microwave ablation will be randomly assigned in a 1:1 ratio to artificial intelligence-guided risk-adapted surveillance or fixed-interval surveillance. In the artificial intelligence-guided group, participants classified as having high, intermediate, or low current recurrence risk will generally undergo the next protocol-scheduled contrast-enhanced imaging examination after 3, 4, or 6 months, respectively. Participants in the control group will undergo protocol-scheduled imaging every 4 months. The risk thresholds are designed so that the expected total number of protocol-scheduled imaging examinations is approximately comparable between the two groups over 24 months.
The artificial intelligence system provides surveillance recommendations only. It does not diagnose recurrence, determine eligibility for liver transplantation, or select anticancer treatment. Clinically indicated examinations may be performed at any time in either group. When recurrence is confirmed, participants in both groups will undergo the same protocol-defined multidisciplinary evaluation, and potentially curative-intent treatment may be considered when clinically appropriate.
The primary purpose is to determine whether artificial intelligence-guided surveillance increases the probability of being alive at 24 months without having a recurrence that is no longer amenable to protocol-defined curative-intent treatment. The study evaluates the timing and allocation of surveillance rather than an adjuvant anticancer treatment and is not intended to prevent the biological occurrence of recurrence.
Age 18 years or older at the time of informed consent.
First diagnosis of hepatocellular carcinoma, confirmed by histopathology for participants undergoing liver resection, or by histopathology or accepted guideline-concordant imaging criteria for participants undergoing thermal ablation.
Completion of first curative-intent treatment consisting of either R0 liver resection with microscopically tumor-negative margins or complete radiofrequency or microwave ablation of all known hepatocellular carcinoma.
Qualifying multiphasic contrast-enhanced CT or MRI obtained 28 to 56 days after completion of the final curative-intent procedure.
Any previous episode of hepatocellular carcinoma or previous hepatocellular carcinoma-directed treatment before the current index diagnosis.
Microscopically or macroscopically positive surgical margins (R1 or R2 resection).
Residual viable tumor after thermal ablation.
Any radiological evidence of residual, recurrent, nodal, or metastatic hepatocellular carcinoma at screening.
Parallel
Artificial Intelligence-Guided Risk-Adapted Surveillance
Other interventionA locked artificial intelligence clinical decision-support system will estimate current recurrence risk from protocol-defined baseline and longitudinal information. Modality-specific model components will be used after liver resection and thermal ablation. Prespecified risk thresholds will map high, intermediate, and low current risk to the next protocol-scheduled contrast-enhanced imaging examination at 3, 4, or 6 months, respectively. The thresholds are calibrated so that the expected aggregate number of protocol-scheduled imaging examinations through Month 24 is approximately comparable with the control strategy. The system does not independently diagnose recurrence or prescribe treatment. Model inputs, outputs, recommendations, clinician overrides, and software versions will be recorded.
Fixed-Interval Surveillance
Other interventionParticipants will undergo contrast-enhanced computed tomography or magnetic resonance imaging every 4 months through Month 24 according to a fixed protocol-defined surveillance schedule. Artificial intelligence risk estimates will not be provided. Unscheduled diagnostic assessment remains permitted when clinically indicated.
Curative-Strategy Failure-Free Survival at 24 Months
Time from randomization to the first occurrence of recurrent hepatocellular carcinoma that a blinded independent central multidisciplinary adjudication committee determines is not amenable to protocol-defined curative-intent liver resection, thermal ablation, or liver transplantation, or death from any cause, whichever occurs first. A recurrence adjudicated as amenable to a protocol-defined curative-intent strategy is not considered an event at that time, and the participant remains under follow-up. The reported metric will be the estimated probability of remaining event-free at Month 24.
Overall Survival
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the data cutoff or whose vital status cannot be confirmed will be censored at the date they were last known to be alive. Vital status will be ascertained using harmonized follow-up procedures in both study groups.
Conventional Recurrence-Free Survival
Recurrence-free survival is defined as the time from randomization to the first confirmed recurrence of hepatocellular carcinoma or death from any cause, whichever occurs first. Recurrence will be determined using protocol-defined imaging and, when clinically indicated, pathological criteria, with blinded independent central review. Participants without recurrence or death will be censored at the date of their last adequate disease assessment.
Curative-Intent Treatment Eligibility at First Recurrence
The proportion of participants with a confirmed first recurrence whose recurrence is adjudicated by a blinded independent central multidisciplinary committee as amenable to at least one protocol-defined curative-intent treatment option, including liver resection, thermal ablation, or liver transplantation. Eligibility will be determined using prespecified clinical and technical criteria and will be assessed independently of whether the treatment is ultimately delivered.
Receipt of Curative-Intent Salvage Treatment
The proportion of participants with a confirmed first recurrence who receive at least one protocol-defined curative-intent salvage treatment, including repeat liver resection, thermal ablation, or liver transplantation. Treatment receipt and curative intent will be documented prospectively. For a prespecified staged curative-intent strategy, the participant will be counted as having received treatment when the first protocol-defined component is initiated.
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