NCT05540925Completed
Vascular Invasion Prediction Via a Multimodal Model Supports Re-staging of Early-stage Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
Effective strategies for personalized treatment decisions for early-stage hepatocellular carcinoma (HCC) remain critically limited. Microvascular invasion (MVI) is a distinctive pathological hallmark of HCC invasiveness. Current evidence underscores that accurate preoperative prediction of MVI has the potential to support personalized selection among surgical resection, liver transplantation, and local ablation, as well as different approaches within each modality. However, despite numerous studies on MVI prediction, accuracy remains insufficient. Currently, radiomics and liquid biopsy are at the forefront of MVI prediction. Furthermore, combining both technologies may offer a more reliable prediction, but this integrated approach remains unexplored. This large-scale prospective cohort study (an observational study design). aims to develop a multimodal approach to predict MVI by integrating four data sources: clinicopathological variables, MRI-based radiomics features, MRI-based deep learning features, and MVI-related genomic alterations detected in circulating cell-free DNA (cfDNA). Individual models will first be developed for each data modality. Their predictive outputs will be calibrated into standardized risk probabilities and integrated via decision-level fusion to generate the final multimodal model. This system will be used to preoperatively stratify patients by predicted MVI risks. Based on this risk stratification, a re-staging system for early-stage HCC will be developed. Its prognostic value and clinical utility will be evaluated, with its ability to guide the selection of optimal resection margins to improve outcomes as a key illustrative example. The primary endpoints are 5-year recurrence-free survival (RFS), 5-year overall survival (OS), and recurrence patterns.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3650 (actual)
- First submitted
- 12 Sept 2022
- Start date
- 1 Jan 2022
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05540925
What you commit to
- Study type: Observational
- Participants enrolled: 3650
- From 1 Jan 2022 to the primary completion date, 30 Apr 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.
Criteria the registry did not label
- Inclusion criteria (1) Age between 18 and 75 years; (2) Histopathologically confirmed HCC; (3) Very early and early-stage HCC meeting BCLC stage 0 or A; (4) Child-Pugh class A or B liver function; (5) Undergoing curative-intent resection, defined as complete tumor removal with tumor-free resection margins, without major vascular invasion or extrahepatic distant metastasis; (6) No preoperative anti-cancer treatment prior to surgery; (7) Availability of preoperative contrast-enhanced MRI data eligible for imaging feature assessment; (8) Availability of preoperative peripheral blood sample for cfDNA sequencing (only for patients with the sequencing); (9) Availability of complete clinicopathological and follow-up data; (10) Written informed consent for research use of clinicopathological data and biological samples.
- Exclusion criteria (1) A history of other malignancies; (2) Residual tumors identified within 2 months after surgery; (3) Serious surgical complications per the Clavien-Dindo classification.
Age in the registry: 18 years to 75 years · 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 |
|---|---|---|---|
| Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.