AI-Based Prediction of HCC Recurrence Patterns After Resection (APAR)
NCT ID: NCT07062380
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
353 participants
OBSERVATIONAL
2025-06-10
2028-06-10
Brief Summary
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The main question it aims to answer is: Can the AI model accurately identify patients at high risk of cancer recurrence within 2 years after surgery? Participants will provide clinical data and undergo standard surgery, followed by 2-year imaging surveillance. Their data will be used for both AI prediction and validation of recurrence patterns.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgery-Only Validation Cohort
Patients with early-stage HCC (BCLC 0-A) receiving curative liver resection without neoadjuvant/adjuvant therapy . Preoperative MRI, clinical data and pathological data will be used for AI model prediction of recurrence risk. Standard follow-up imaging for 2 years will validate model accuracy.
Curative liver resection
Standard radical hepatectomy performed according to 2024 HCC guidelines. No neoadjuvant or adjuvant therapies administered. Follows institutional surgical protocols for BCLC 0-A HCC.
Exploratory Treatment Cohort
Patients with early-stage HCC receiving real-world neoadjuvant/adjuvant therapies (per physician discretion) alongside surgery. Treatment regimens and outcomes (RFS/OS) will be analyzed to assess therapy efficacy in model-stratified high/low-risk subgroups.
Real-world multimodal therapy
Curative resection combined with clinically indicated therapies (e.g., TACE, targeted drugs, immunotherapy) as per treating physician's decision. Treatments recorded but not protocol-mandated.
Interventions
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Curative liver resection
Standard radical hepatectomy performed according to 2024 HCC guidelines. No neoadjuvant or adjuvant therapies administered. Follows institutional surgical protocols for BCLC 0-A HCC.
Real-world multimodal therapy
Curative resection combined with clinically indicated therapies (e.g., TACE, targeted drugs, immunotherapy) as per treating physician's decision. Treatments recorded but not protocol-mandated.
Eligibility Criteria
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Inclusion Criteria
* BCLC stage 0-A, scheduled for curative liver resection.
* Preoperative clinical diagnosis of hepatocellular carcinoma (HCC).
* Availability of dynamic contrast-enhanced MRI within 1 month before surgery, with acceptable image quality.
* Child-Pugh liver function score ≤7.
* ECOG Performance Status (PS) 0-1.
* No severe organic diseases of the heart, lungs, brain, or other vital organs.
Exclusion Criteria
* Postoperative pathology confirms non-HCC diagnosis.
* Pregnant or lactating women.
* History of organ transplantation.
* Inability to comply with the study protocol or follow-up schedule.
18 Years
75 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Wan-Guang Zhang
professor
Locations
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Tongji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TJ-IRB202505060
Identifier Type: -
Identifier Source: org_study_id
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