RecruitingNCT07062380

AI-Based Prediction of HCC Recurrence Patterns After Resection (APAR)

Prospective Validation of Multimodal Deep Learning Models for Predicting Recurrence Patterns in Early-Stage Hepatocellular Carcinoma After Resection: A Natural Treatment Cohort Stratification Study


Sponsor

Tongji Hospital

Enrollment

353 participants

Start Date

Jun 10, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This observational study aims to validate a deep learning model for predicting aggressive recurrence patterns in patients with early-stage liver cancer (HCC) after surgery. 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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

  • Aged 18-75 years, regardless of gender.
  • 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 Criteria5

  • Concurrent other malignancies (except cured non-melanoma skin cancer or cervical carcinoma in situ).
  • 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.

Interventions

PROCEDURECurative 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.

PROCEDUREReal-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.


Locations(1)

Tongji Hospital

Wuhan, Hubei, China

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NCT07062380


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