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

NCT07732504 | Not Yet Recruiting DMC

• 1 other identifier: HCC-AI-RECLAIM-01
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Artificial Intelligence; Risk-Adapted Surveillance; Recurrence Surveillance; Early Detection of Recurrence; Clinical Decision Support; Liver Resection; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization through Month 24

Secondary Outcomes (11)

• Overall Survival

  From randomization through Month 36

• Conventional Recurrence-Free Survival

  From randomization through Month 36

• Curative-Intent Treatment Eligibility at First Recurrence

  At the first confirmed recurrence occurring from randomization through Month 24

• Receipt of Curative-Intent Salvage Treatment

  From confirmation of first recurrence through 12 months after recurrence, for recurrences occurring through Month 24

• Complete Response After Curative-Intent Salvage

  Within 12 weeks after completion of the first curative-intent salvage treatment

Study Arms (2)

AI-Guided Risk-Adapted Surveillance

EXPERIMENTAL

Participants will receive a locked artificial intelligence-guided risk-adapted surveillance strategy during the 24-month primary intervention period. Current recurrence risk will be reassessed using protocol-defined clinical, laboratory, and imaging information. Participants classified as having high, intermediate, or low current risk will generally undergo their next protocol-scheduled contrast-enhanced imaging examination after 3, 4, or 6 months, respectively. Protocol-defined clinical or tumor-marker changes may trigger expedited diagnostic evaluation. Clinically indicated examinations may be performed at any time. The artificial intelligence system provides surveillance recommendations only and does not diagnose recurrence or select anticancer treatment.

Other: Artificial Intelligence-Guided Risk-Adapted Surveillance

Fixed-Interval Surveillance

ACTIVE COMPARATOR

Participants will undergo protocol-scheduled contrast-enhanced surveillance imaging every 4 months during the 24-month primary intervention period. Clinical assessments and tumor-marker testing will follow the same protocol-defined schedule used in the experimental group. Clinically indicated examinations may be performed at any time. Suspected recurrence will undergo the same confirmation procedures, central review, multidisciplinary evaluation, and access to guideline-concordant treatment used in the experimental group. Artificial intelligence risk estimates and surveillance recommendations will not be displayed.

Other: Fixed-Interval Surveillance

Interventions

Artificial Intelligence-Guided Risk-Adapted Surveillance OTHER

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.

AI-Guided Risk-Adapted Surveillance

Fixed-Interval Surveillance OTHER

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.

Fixed-Interval Surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Zhao Huang

  Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhao Huang, M.D

CONTACT

+86 13006378908; huangzhao@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and treating clinicians cannot be masked because the surveillance intervals differ between groups. Radiologists performing independent central imaging review and members of the central multidisciplinary committee adjudicating recurrence and eligibility for protocol-defined curative-intent treatment will remain unaware of randomized assignment. Group identifiers will be concealed in materials provided for central outcome adjudication.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Participants will be randomized individually in a 1:1 ratio to a locked artificial intelligence-guided risk-adapted surveillance strategy or a fixed-interval surveillance strategy. Randomization will be implemented centrally and stratified by study center and initial curative-intent treatment modality, defined as microscopically margin-negative liver resection versus radiofrequency or microwave ablation. Participants will remain in their assigned surveillance strategy throughout the 24-month primary trial period. Both groups will use the same procedures for confirming suspected recurrence and the same multidisciplinary recurrence-management pathway; the principal difference between groups will be the timing of protocol-scheduled surveillance imaging.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available beginning 12 months after publication of the primary trial results and will remain available for 5 years.
• Access Criteria: Access may be granted to qualified researchers who submit a methodologically sound research proposal for purposes such as verification of the published findings, approved secondary analyses, or individual participant data meta-analyses. Requests will be reviewed by a designated data access committee. Approved researchers must obtain any required ethics approval, sign a data-use agreement, use the data only for the approved purpose, protect confidentiality, and agree not to attempt participant re-identification. Data will be provided through a secure controlled-access mechanism.

Locations

CN (1)