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

NCT ID: NCT07062380

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-10

Study Completion Date

2028-06-10

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatecellular Carcinoma Hepatectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Curative liver resection

Intervention Type 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.

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.

Real-world multimodal therapy

Intervention Type 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.

Interventions

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Curative liver resection

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

Intervention Type PROCEDURE

Real-world multimodal therapy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wan-Guang Zhang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Wu, M.D.

Role: CONTACT

+8613636076910

Facility Contacts

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Wanguang Zhang

Role: primary

13636076910

Other Identifiers

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TJ-IRB202505060

Identifier Type: -

Identifier Source: org_study_id

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