Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-Assisted Evaluation | Diagnostic Test | — | UNRESOLVED |
| Unassisted Independent Evaluation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group A Evaluators
- description
- 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.
- interventionNames
- Diagnostic Test: Unassisted Independent Evaluation
- Diagnostic Test: AI-Assisted Evaluation
- label
- Group B Evaluators
- description
- 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.
- interventionNames
- Diagnostic Test: Unassisted Independent Evaluation
- Diagnostic Test: AI-Assisted Evaluation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available