Actively Recruiting

Age: 18Years - 75Years
All Genders
ID07062380

Prospective Validation of AI Models for Predicting Recurrence in Early-Stage Liver Cancer After Surgery

Led by Tongji Hospital · Updated on 2025-09-03

353

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a deep learning model to predict aggressive patterns of cancer recurrence in patients with early-stage hepatocellular carcinoma (HCC) after liver surgery. This observational study aims to find out if the AI model can accurately identify patients at high risk of cancer returning within two years after surgery. The study is sponsored by Tongji Hospital and focuses on patients undergoing curative liver resection without prior or additional therapies, as well as those receiving real-world neoadjuvant or adjuvant treatments. Participants will be divided into two groups: one receiving standard curative liver resection alone and another receiving surgery combined with various physician-directed therapies such as targeted drugs or immunotherapy. Before surgery, patients will undergo MRI scans and provide clinical and pathological data to help the AI model predict recurrence risk. After surgery, all participants will have standard imaging follow-up for two years to validate how well the AI predicts recurrence. During the study, participants will provide clinical information and undergo routine imaging surveillance to monitor cancer recurrence and overall survival for up to five years. Researchers will measure the accuracy of the AI model in predicting aggressive recurrence within two years as the primary outcome. Secondary outcomes include recurrence-free and overall survival over longer periods. The study involves no experimental treatments but carefully observes real-world outcomes and AI predictions over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years, regardless of gender
  • Diagnosed with early-stage hepatocellular carcinoma (BCLC stage 0-A)
  • Scheduled for curative liver resection surgery
  • Have a dynamic contrast-enhanced MRI within 1 month before surgery with acceptable quality
  • Child-Pugh liver function score of 7 or less
  • ECOG Performance Status of 0 or 1
  • No severe diseases affecting heart, lungs, brain, or other vital organs
Not Eligible

You will not qualify if you...

  • Having other active cancers except cured non-melanoma skin cancer or cervical carcinoma in situ
  • Postoperative pathology shows diagnosis other than hepatocellular carcinoma
  • Pregnant or breastfeeding women
  • History of organ transplantation
  • Unable to follow the study protocol or attend follow-up visits

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery

Duration - 1 day

Participants undergo curative liver resection surgery according to standard clinical protocols for early-stage liver cancer.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 5 years

Participants are followed with standard imaging and clinical assessments to monitor for cancer recurrence and overall health.

Regular imaging and clinical visits over 2 to 5 years

Trial Site Locations

Total: 1 location

1

Tongji Hospital

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

Y

Yang Wu, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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