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

Tongji Hospital

Status: Enrolling

Conditions: Hepatectomy; Hepatecellular Carcinoma

Treatments: Procedure: Curative liver resection; Procedure: Real-world multimodal therapy

Study type: Observational

Funder types: Other

Identifiers

NCT07062380

TJ-IRB202505060

Details and patient eligibility

About

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.

Enrollment: 353 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

353 participants in 2 patient groups

Surgery-Only Validation Cohort

Description:

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.

Treatment:

Procedure: Curative liver resection

Exploratory Treatment Cohort

Description:

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.

Treatment:

Procedure: Real-world multimodal therapy