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Active, not recruitingNCT07658586AIM-LCAPUpdated Jul 1, 2026

AI Multimodal Model for Liver Cancer Diagnosis and Prognosis

An observational study in Liver Cancer, Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma (Icc), sponsored by Guangxi Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Guangxi Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years to 80 Years
Sex
All
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Study summary

This study aims to develop a comprehensive artificial intelligence model system integrating preoperative multimodal data (CT/MRI imaging, clinical laboratory data, and radiology report text) to achieve two core objectives. First, to develop a multimodal fusion diagnostic model for non-invasive and accurate preoperative differentiation of liver cancer subtypes, including distinguishing benign from malignant lesions and differentiating hepatocellular carcinoma from intrahepatic cholangiocarcinoma. Second, to develop a prognostic prediction model for patients with confirmed liver cancer undergoing radical surgery to assess postoperative progression-free survival and overall survival. This is a multicenter retrospective cohort study with an anticipated sample size of ≥600 patients. Model performance will be evaluated using AUC, accuracy, sensitivity, specificity, C-index, and calibration curves. Subgroup analysis will be conducted based on whether patients received neoadjuvant therapy.

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Conditions studied

  • Liver Cancer
  • Hepatocellular Carcinoma
  • Intrahepatic Cholangiocarcinoma (Icc)
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In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 600 is above the median of 200 across 350 observational studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Guangxi Medical University is the lead sponsor of 68 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

(1) Key clinical, imaging, or pathological data severely missing or incomplete; (2) Preoperative CT or MRI images of poor quality or missing sequences, unable to perform reliable image analysis; (3) Prior local treatment for the target liver lesion, unless clearly recorded as neoadjuvant therapy before surgery; (4) Concurrent other malignant tumors; (5) Lost to follow-up or follow-up data cannot meet endpoint determination requirements.

Inclusion criteria

-Diagnostic Model Cohort:

  • Age ≥18 years
  • Underwent preoperative contrast-enhanced CT or MRI for clinically suspected liver space-occupying lesion
  • Have complete preoperative clinical laboratory data
  • Have complete original CT/MRI imaging data and radiology reports
  • Have definite pathological diagnosis from surgery or biopsy as gold standard

Prognostic Prediction Model Cohort (selected from diagnostic cohort):

  • Meet all diagnostic cohort inclusion criteria
  • Pathologically confirmed liver cancer
  • Underwent radical hepatectomy
  • Have complete preoperative multimodal data (CT/MRI imaging, clinical laboratory data, radiology reports)
  • Have complete postoperative follow-up data to determine progression-free survival and overall survival endpoints and time (minimum follow-up of 24 months)

Exclusion criteria

Exclusion Criteria:

    • Key clinical, imaging, or pathological data severely missing or incomplete

      • Preoperative CT or MRI images of poor quality or missing sequences, unable to perform reliable image analysis
      • Prior local treatment for the target liver lesion, unless clearly recorded as neoadjuvant therapy before surgery
      • Concurrent other malignant tumors
      • Lost to follow-up or follow-up data cannot meet endpoint determination requirements
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • Diagnostic

    Diagnostic Model Cohort: Patients with suspected liver space-occupying lesions who underwent preoperative contrast-enhanced CT or MRI and have definite pathological diagnosis (surgical or biopsy) as gold standard.

  • Prognostic

    Prognostic Prediction Model Cohort: Patients selected from the diagnostic cohort who were pathologically diagnosed with liver cancer, received radical hepatectomy, and have complete postoperative follow-up data (minimum 24 months) to determine progression-free survival and overall survival endpoints.

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What researchers measure

Primary outcomes

  1. Diagnostic Accuracy of the Multimodal AI Model for Liver Lesion Classification

    The diagnostic performance of the multimodal AI model in differentiating benign from malignant liver lesions and distinguishing hepatocellular carcinoma from intrahepatic cholangiocarcinoma, evaluated using pathology results as the gold standard. Performance metrics include area under the receiver operating characteristic curve (AUC), accuracy, sensitivity, and specificity.

    Time frame: At the time of initial diagnosis

  2. Prognostic Performance of the Multimodal AI Model for Postoperative Survival Prediction

    The prognostic performance of the multimodal AI model in predicting postoperative progression-free survival (PFS) and overall survival (OS) in patients with pathologically confirmed liver cancer who underwent radical hepatectomy. Performance metric includes the concordance index (C-index). Calibration curves are also assessed.

    Time frame: minimum follow-up of 24 months

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Study locations

1 site
  • Guangxi Medical University First Affiliated Hospital
    Nanning, Guangxi, China
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References and documents

Publications

  • Di Martino F, Delmastro F. Explainable AI for clinical and remote health applications: a survey on tabular and time series data. Artif Intell Rev. 2023;56(6):5261-5315. doi: 10.1007/s10462-022-10304-3. Epub 2022 Oct 26. PubMed 36320613 ↗
  • Xu P, Zhu X, Clifton DA. Multimodal Learning With Transformers: A Survey. IEEE Trans Pattern Anal Mach Intell. 2023 Oct;45(10):12113-12132. doi: 10.1109/TPAMI.2023.3275156. Epub 2023 Sep 5. PubMed 37167049 ↗
  • Schmauch B, Elsoukkary SS, Moro A, Raj R, Wehrle CJ, Sasaki K, Calderaro J, Sin-Chan P, Aucejo F, Roberts DE. Combining a deep learning model with clinical data better predicts hepatocellular carcinoma behavior following surgery. J Pathol Inform. 2023 Dec 29;15:100360. doi: 10.1016/j.jpi.2023.100360. eCollection 2024 Dec. PubMed 38292073 ↗
  • Ji GW, Zhu FP, Xu Q, Wang K, Wu MY, Tang WW, Li XC, Wang XH. Radiomic Features at Contrast-enhanced CT Predict Recurrence in Early Stage Hepatocellular Carcinoma: A Multi-Institutional Study. Radiology. 2020 Mar;294(3):568-579. doi: 10.1148/radiol.2020191470. Epub 2020 Jan 14. PubMed 31934830 ↗
  • Peng J, Kang S, Ning Z, Deng H, Shen J, Xu Y, Zhang J, Zhao W, Li X, Gong W, Huang J, Liu L. Residual convolutional neural network for predicting response of transarterial chemoembolization in hepatocellular carcinoma from CT imaging. Eur Radiol. 2020 Jan;30(1):413-424. doi: 10.1007/s00330-019-06318-1. Epub 2019 Jul 22. PubMed 31332558 ↗
  • Castaldo A, De Lucia DR, Pontillo G, Gatti M, Cocozza S, Ugga L, Cuocolo R. State of the Art in Artificial Intelligence and Radiomics in Hepatocellular Carcinoma. Diagnostics (Basel). 2021 Jun 30;11(7):1194. doi: 10.3390/diagnostics11071194. PubMed 34209197 ↗
  • Wang C, Wei F, Sun X, Qiu W, Yu Y, Sun D, Zhi Y, Li J, Fan Z, Lv G, Wang G. Exploring potential predictive biomarkers through historical perspectives on the evolution of systemic therapies into the emergence of neoadjuvant therapy for the treatment of hepatocellular carcinoma. Front Oncol. 2024 Jun 27;14:1429919. doi: 10.3389/fonc.2024.1429919. eCollection 2024. PubMed 38993637 ↗
  • He Z, She X, Liu Z, Gao X, Lu LU, Huang J, Lu C, Lin Y, Liang R, Ye J. Advances in post-operative prognostic models for hepatocellular carcinoma. J Zhejiang Univ Sci B. 2023 Mar 15;24(3):191-206. doi: 10.1631/jzus.B2200067. PubMed 36915996 ↗
  • Herden U, Schoening W, Pratschke J, Manekeller S, Paul A, Linke R, Lorf T, Lehner F, Braun F, Stippel DL, Sucher R, Schmidt H, Strassburg CP, Guba M, van Rosmalen M, Rogiers X, Samuel U, Schon GM, Nashan B. Accuracy of Pretransplant Imaging Diagnostic for Hepatocellular Carcinoma: A Retrospective German Multicenter Study. Can J Gastroenterol Hepatol. 2019 Mar 5;2019:8747438. doi: 10.1155/2019/8747438. eCollection 2019. PubMed 30949459 ↗
  • Saito R, Amemiya H, Hosomura N, Kawaida H, Maruyama S, Shimizu H, Furuya S, Akaike H, Kawaguchi Y, Sudo M, Inoue S, Kono H, Ichikawa D. Prognostic Significance of Treatment Strategies for the Recurrent Hepatocellular Carcinomas After Radical Resection. In Vivo. 2020 May-Jun;34(3):1265-1270. doi: 10.21873/invivo.11900. PubMed 32354917 ↗
  • Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PubMed 38572751 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07658586
Lead sponsor
Guangxi Medical University
Responsible party
Fubo Wang (Doctor of Medicine, Guangxi Medical University) — Principal investigator
First posted
Jun 22, 2026
Start date
Dec 1, 2025
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Jul 1, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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