Precision Recurrence Risk Assessment in Early-stage Hepatocellular Carcinoma

Completed

• Conditions: Hepatocellular Carcinoma (HCC)

• Registration Number: NCT07030842
• Lead Sponsor: Tongji Hospital

Brief Summary

This retrospective observational study aims to evaluate whether artificial intelligence (AI) models can predict aggressive recurrence in patients who underwent liver resection for early-stage hepatocellular carcinoma (HCC). The main question it seeks to answer is:

Can deep learning models combining preoperative MRI, postoperative pathology slides, and clinical data accurately identify HCC patients at high risk of aggressive recurrence after surgery?

To answer this, the investigators will analyze existing medical data (preoperative MRIs, postoperative whole-slide images, and clinical records) from 579 patients across two medical centers. All data will be anonymized before analysis, and no additional interventions are required from participants.

This study may help clinicians stratify high-risk patients who could benefit from closer surveillance or adjuvant therapies

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-25
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 579

Inclusion Criteria

• Patients who underwent curative liver resection (R0) for pathologically confirmed primary HCC
• BCLC stage 0-A at diagnosis
• Availability of preoperative contrast-enhanced MRI performed within 1 month before surgery
• Availability of postoperative H&E-stained whole slide images (WSIs) with adequate tumor representation
• Complete clinical follow-up data (minimum 2 years if no recurrence)

Exclusion Criteria

• R1/R2 resection (micro/macroscopically positive margins)
• Missing or poor-quality preoperative MRI (motion artifacts/insufficient contrast enhancement)
• Received neoadjuvant or adjuvant therapy (to avoid treatment confounding)
• Incomplete follow-up (loss to follow-up or missing recurrence status)
• Non-curative procedures (e.g., palliative resection)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aggressive Recurrence Pattern	2 years after surgery	Defined as first recurrence exceeding Milan criteria within 2 years after liver resection.

Secondary Outcome Measures

Name	Time	Method
Recurrence-Free Survival (RFS)	From surgery until first recurrence or July 30, 2024	Time from surgery date to radiologically confirmed recurrence or last follow-up (until July 30, 2024).
Overall Survival (OS)	From surgery until death or July 30, 2024	Time from surgery date to death from any cause or last follow-up.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China