NCT07538882Recruiting
AI-Assisted Staging and Treatment Decision-Making for Hepatocellular Carcinoma
A Prospective, Randomized, Controlled, Crossover Study of Artificial Intelligence-Assisted Multi-Dimensional Staging and Treatment Decision-Making for Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 108 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 13 Apr 2026
- Primary completion date
- 13 May 2026
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07538882
What you commit to
- Study type: Observational
- Planned participants: 108
- From 13 Apr 2026 to the primary completion date, 13 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with secondary (metastatic) liver cancer or concurrent severe malignancies of other systems.
- Patients who have previously received anti-tumor therapies for liver cancer prior to enrollment.
Lab values
- Patients who fail to complete the required baseline imaging or laboratory tests, preventing accurate staging calculation (e.g., missing data for Child-Pugh score).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tsinghua Changgung Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.