AI-Assisted Staging and Treatment Decision-Making for Hepatocellular Carcinoma

NCT07538882 | Recruiting

• 1 other identifier: 25532-4-01
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The precise treatment of primary hepatocellular carcinoma (HCC) highly depends on accurate disease staging (CNLC, TNM, BCLC) and scientific treatment decision-making, which necessitate the integration of both imaging and clinical baseline data. This study prospectively recruits HCC patients and clinical physicians across different hospital tiers to evaluate the clinical value of a self-developed artificial intelligence (AI) model in assisting multi-dimensional comprehensive assessment and treatment decision-making. Utilizing a Multi-Rater Multi-Case (MRMC) crossover balanced design, the study compares the accuracy of clinical evaluations performed by physicians under "unassisted (without AI)" versus "AI-assisted" conditions. A key focus is to explore whether AI can significantly enhance the comprehensive assessment capabilities of physicians in primary/secondary care hospitals, thereby prospectively reducing diagnostic and therapeutic heterogeneity across different institutional levels.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Hepatocellular Carcinoma; Artificial Intelligence; Staging; Clinical Decision-Making; Diagnostic Accuracy

Outcome Measures

Primary Outcomes (1)

• Improvement in Overall Accuracy

  The difference in average accuracy across the 4 classification tasks between AI-assisted evaluation (experimental) and independent evaluation (control). Accuracy is determined by comparing physicians' predictions against the reference standard (Ground Truth) established by the independent expert panel

  Up to 1 week (Assessed upon completion of all case evaluations)

Secondary Outcomes (3)

• Homogenization Effect on Evaluation Accuracy

  Up to 1 week (Assessed upon completion of all case evaluations)

• Evaluation Efficiency (Average Time per Case)

  Up to 1 week (Assessed upon completion of all case evaluations)

• Inter-rater Agreement

  Up to 1 week (Assessed upon completion of all case evaluations)

Study Arms (2)

Group A Evaluators

A prospectively recruited group of 6 physicians (2 tertiary senior, 2 tertiary junior, and 2 primary/secondary hospital physicians). In Phase 1 (Control), they independently evaluate HCC case Set A without AI assistance. In Phase 2 (Experimental), they evaluate case Set B with the assistance of the AI model.

Diagnostic Test: Unassisted Independent Evaluation; Diagnostic Test: AI-Assisted Evaluation

Group B Evaluators

A prospectively recruited group of 6 physicians (2 tertiary senior, 2 tertiary junior, and 2 primary/secondary hospital physicians). In Phase 1 (Control), they independently evaluate HCC case Set B without AI assistance. In Phase 2 (Experimental), they evaluate case Set A with the assistance of the AI model.

Diagnostic Test: Unassisted Independent Evaluation; Diagnostic Test: AI-Assisted Evaluation

Interventions

Unassisted Independent Evaluation DIAGNOSTIC_TEST

Physicians independently evaluate the HCC cases and provide staging and treatment decisions using only complete clinical baseline data and imaging data, without any assistance from the AI model.

Group A Evaluators; Group B Evaluators

AI-Assisted Evaluation DIAGNOSTIC_TEST

Physicians evaluate the HCC cases and provide final staging and treatment decisions after reviewing the initial predictions and related evidence generated by the self-developed artificial intelligence (AI) model, alongside the clinical baseline and imaging data.

Group A Evaluators; Group B Evaluators

Eligibility Criteria

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

Study Population

The study population comprises 108 prospectively and consecutively enrolled adult patients with newly diagnosed primary hepatocellular carcinoma (HCC). Following enrollment and confirmation of complete baseline clinical and imaging data, these 108 patient cases are randomly divided into two equal datasets: Set A (54 cases) and Set B (54 cases). Randomization is stratified to ensure no statistically significant differences between the two sets regarding baseline characteristics such as tumor burden, liver function grading, and staging distribution. In the context of this multi-rater multi-case (MRMC) crossover design, these patient cases are allocated to distinct evaluation conditions. Set A cases are assigned to be evaluated by the first group of reviewing physicians without AI assistance (control condition) and by the second group of physicians with AI assistance (experimental condition). Conversely, Set B cases are evaluated by the second group of physicians without AI

You may qualify if:

• Age \>= 18 years.
• Patients prospectively presenting with suspected or newly diagnosed primary hepatocellular carcinoma (HCC) later confirmed by pathology or meeting the China Liver Cancer (CNLC) guidelines.
• Complete baseline clinical data acquired during the prospective enrollment period, including complete history of present/past illness, ECOG PS score, comprehensive laboratory tests (liver function, coagulation, tumor markers such as AFP, etc.), and baseline abdominal contrast-enhanced CT.
• Patients (or their legal representatives) must provide written informed consent for their clinical data to be used in this trial.

You may not qualify if:

• Patients with secondary (metastatic) liver cancer or concurrent severe malignancies of other systems.
• Patients who fail to complete the required baseline imaging or laboratory tests, preventing accurate staging calculation (e.g., missing data for Child-Pugh score).
• Patients who have previously received anti-tumor therapies for liver cancer prior to enrollment.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Affiliated Hospital of Hebei University: collaborator
• Meng Chao Hepatobiliary Hospital of Fujian Medical University: collaborator
• Zhongnan Hospital: collaborator
• Xingtai People's Hospital: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• Xinan hospital of Army Medical University: collaborator

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Changping, 102218, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jiahong Dong

  Beijing Tsinghua Changgeng Hospital

  STUDY CHAIR

Central Study Contacts

Jitao Wang

CONTACT

+8618632957579; wjta05045@btch.edu.cn

Study Design

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

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): May 13, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)