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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Yang Wu, M.D.
255001907@qq.com
+8613636076910
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2028-06-10
Participants
Target number of participants: 353
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Tongji Hospital

This content was sourced from clinicaltrials.gov