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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Tsinghua Chang Gung Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Unassisted Independent Evaluation
  • AI-Assisted Evaluation

Treatment groups

108 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Tsinghua Chang Gung Hospital

Lead sponsor

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