Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS) | Time from surgery to first radiologically confirmed recurrence (any pattern) or death from any cause, analyzed by Kaplan-Meier method and compared between model-predicted high/low-risk groups. Unit : Months | Up to 3 years |
| Overall Survival (OS) |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Efficacy in Exploratory Cohort | Objective response rate (ORR) and RFS/OS benefits of neoadjuvantin model-predicted high-risk patients, assessed descriptively (non-randomized comparison). Unit : Percentage (%) | Up to 1 years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Wu, M.D. | Contact | +8613636076910 | 255001907@qq.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
Time from surgery to death from any cause, compared between patients stratified by AI model predictions (high-risk vs. low-risk) and treatment cohorts (surgery-only vs. real-world therapy). Unit : Months |
| Up to 5 years |