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

NCT07062380 | Recruiting

• 1 other identifier: TJ-IRB202505060
• Study Type: observational
• Target: 353
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatecellular Carcinoma; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• Accuracy of AI Model in Predicting Aggressive HCC Recurrence (AUC)

  The area under the receiver operating characteristic curve (AUC) of the multimodal deep learning model (PRE/POST) for predicting postoperative recurrence beyond Milan criteria within 2 years after resection, validated against actual imaging/histopathology-confirmed recurrence patterns. Unit : Dimensionless (0-1)

  2 years post-surgery

Secondary Outcomes (2)

• Recurrence-Free Survival (RFS)

  Up to 3 years

• Overall Survival (OS)

  Up to 5 years

Other Outcomes (1)

• Therapeutic Efficacy in Exploratory Cohort

  Up to 1 years

Study Arms (2)

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.

Procedure: Curative liver resection

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.

Procedure: Real-world multimodal therapy

Interventions

Curative liver resection PROCEDURE

Standard radical hepatectomy performed according to 2024 HCC guidelines. No neoadjuvant or adjuvant therapies administered. Follows institutional surgical protocols for BCLC 0-A HCC.

Surgery-Only Validation Cohort

Real-world multimodal therapy PROCEDURE

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.

Exploratory Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll patients with early-stage hepatocellular carcinoma (BCLC 0-A) scheduled for curative liver resection at tertiary academic medical centers in China. Participants will be consecutively recruited from hepatobiliary surgery clinics, with preoperative MRI and postoperative pathology confirmation of HCC. The population reflects real-world clinical practice, including both surgery-only patients and those receiving neoadjuvant/adjuvant therapies per physician discretion.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Central Study Contacts

Yang Wu, M.D.

CONTACT

+8613636076910; 255001907@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): June 10, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)