AI-assisted staging and treatment decisions for hepatocellular carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multi-center study enrolls adults with suspected or newly diagnosed primary hepatocellular carcinoma and compares physician decisions made with and without an AI assistance tool using a balanced multi-rater, multi-case crossover design. Physicians from different hospital tiers review the same imaging and baseline clinical data under unassisted and AI-assisted conditions, and their staging (CNLC, TNM, BCLC) and treatment recommendations are recorded. An independent three-expert panel establishes the reference standard using full imaging, clinical data, and multidisciplinary discussion. The design specifically examines whether AI reduces diagnostic and therapeutic variability between primary/secondary hospitals and higher-tier centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Beijing Tsinghua Changgung Hospital
  Beijing, Changping, China Recruiting

Study contacts

• Study coordinator: Jitao Wang
• Email: wjta05045@btch.edu.cn
• Phone: +8618632957579

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.