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

NCT07732504 · tracked via the Priya Life Science China tracker

Sponsor

Tongji Hospital

Phase

Not applicable

Started

2026-10-01

Last updated

2026-07-29

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

Artificial Intelligence-Guided Risk-Adapted SurveillanceFixed-Interval Surveillance

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. * Qualifying imaging confirming no viable tumor at the resection bed or ablation site, no new intrahepatic hepatocellular carcinoma, and no macrovascular invasion, regional nodal disease, or extrahepatic metastasis. * No unresolved lesion requiring immediate diagnostic evaluation or treatment at the time of randomization. * Randomization within 14 days after the qualifying post-treatment imaging assessment and before the first protocol-scheduled surveillance examination. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Child-Pugh class A liver function. * Medically fit for at least one protocol-defined curative-intent salvage treatment should an anatomically amenable recurrence be detected. * Able to undergo repeated protocol-required multiphasic contrast-enhanced CT or MRI examinations. * Availability of the minimum mandatory baseline data elements required to generate an output from the locked artificial intelligence system. * Able and willing to comply with trial procedures and provide written informed consent. Exclusion Criteria: * 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. * Macrovascular invasion, regional lymph-node metastasis, or extrahepatic metastasis associated with the index hepatocellular carcinoma. * Index treatment involving liver transplantation, combined resection and ablation, transarterial therapy, radiotherapy, systemic anticancer therapy, or another hepatocellular carcinoma-directed treatment other than the qualifying R0 resection or complete radiofrequency or microwave ablation. * Previous liver transplantation, active placement on a liver-transplant waiting list, or planned liver transplantation in the absence of documented recurrent hepatocellular carcinoma. * Planned or ongoing adjuvant antineoplastic treatment intended to reduce hepatocellular carcinoma recurrence after the qualifying procedure. Guideline-concordant antiviral treatment and management of the underlying liver disease are permitted. * Concurrent participation in another interventional study expected to affect hepatocellular carcinoma recurrence, survival, surveillance intensity, or eligibility for curative-intent salvage treatment. * Combined hepatocellular-cholangiocarcinoma or another non-hepatocellular primary hepatic malignancy. * A permanent medical contraindication that would preclude all protocol-defined curative-intent salvage treatment options. * Inability to undergo any protocol-permitted contrast-enhanced CT or MRI modality because of contraindication to all available imaging and contrast options. * Active malignancy other than hepatocellular carcinoma that requires anticancer treatment or is expected to materially interfere with survival, surveillance adherence, or outcome assessment during the primary 24-month follow-up period. * Uncontrolled hepatic decompensation, including refractory ascites or clinically significant hepatic encephalopathy. * Pregnancy at the time of randomization. * Inability or unwillingness to provide informed consent or comply with protocol-specified follow-up.

Primary outcome measure(s)

Curative-Strategy Failure-Free Survival at 24 Months — From randomization through Month 24
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.

Trial sites (1)

Facility	City	Region	Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

More Tongji Hospital trials in China

SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer Starting soon

Safety, Tolerability, and Preliminary Efficacy of KD01 Via Intravesical Instillation in Bladder Cancer (BC) Recruiting

Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC Recruiting

Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease Recruiting

Lenvatinib Plus PD-1 Inhibitor for Advanced Solid Tumors With 11q13 Amplification Recruiting

Other trials for the same condition

GKL-006 Injection Plus TACE Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma Recruiting

Toripalimab Plus Bevacizumab Combined Three Intra-arterial Therapies (TACE, HAIC, or TACE-HAIC) for Unresectable Hepatocellular Carcinoma: a Phase 2, Multicenter Randomised Non-comparative Trial Active, not recruiting

Hepatic Arterial Infusion Chemotherapy and Immunotherapy for Hepatocellular Carcinoma Recruiting

NWRD06 DNA Plasmid for HCC After Curative Resection. Recruiting

A Clinical Study on the Safety, Tolerability and Efficacy of Neoantigen-based Personalized mRNA Therapy iNeo-Vac-R01 Plus PD-1 Inhibitor in Adjuvant Treatment of Liver Cancer Post Radical Resection Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07732504 on ClinicalTrials.gov ↗ ← All trials in China