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Recruiting NCT07062380

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

Observational Hepatecellular Carcinoma Hepatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Curative liver resection, Real-world multimodal therapy.
Who it may be relevant to
Registry conditions: Hepatecellular Carcinoma, Hepatectomy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure 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.
  • Procedure 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.

Primary outcome measures

  • Accuracy of AI Model in Predicting Aggressive HCC Recurrence (AUC) [Time frame: 2 years post-surgery]
Secondary outcome measures (2)
  • Recurrence-Free Survival (RFS) [Time frame: Up to 3 years]
  • Overall Survival (OS) [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Tongji Hospital — Wuhan

Identifiers

NCT: NCT07062380 · TJ-IRB202505060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗