AI-Guided Surveillance and Curative Salvage of Recurrence After Hepatocellular Carcinoma Resection or Ablation

Summary

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.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

OTHER

Artificial Intelligence-Guided Risk-Adapted Surveillance

A 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.

OTHER

Fixed-Interval Surveillance

Participants 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.

Sponsors & Collaborators

• Tongji Hospital

  lead OTHER

Principal Investigators

• Zhao Huang · Tongji Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2029-12-31

Completion

2030-12-31

Countries

• China

Study Locations