NCT07700082

Brief Summary

This is a completed multi-center retrospective observational study focusing on patients who received curative surgical resection for hepatocellular carcinoma (HCC). We collected anonymized historical clinical data, preoperative gadoxetic acid-enhanced MRI scans and digital pathological whole-slide images from three Chinese medical centers and the public TCGA-LIHC database. We developed a multimodal hybrid deep learning prognostic model (named HCC-MPDS) integrating multi-source medical data to stratify HCC patients into high-risk and low-risk recurrence groups after surgery. The primary goal of this study is to compare postoperative recurrence-free survival (RFS) and overall survival (OS) between the two risk subgroups, and evaluate whether this artificial intelligence prediction system can help clinicians identify patients who may benefit from postoperative adjuvant therapy. No new experimental drugs or interventional treatments were provided to participants; all data were retrospectively extracted from archived medical records under institutional ethics approval, with waived written informed consent for de-identified historical samples and images.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
555

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

5 years

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrence-Free Survival (RFS)

    Time from surgical resection to first local/regional recurrence, distant metastasis or all-cause death, whichever occurs first

    Up to 60 months after hepatectomy

Study Arms (2)

MPDS High-risk patients (risk score > -1.76)

MPDS Low-risk patients (risk score ≤ -1.76)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of 555 adult patients with pathologically confirmed hepatocellular carcinoma who underwent curative hepatectomy. All subjects had complete preoperative gadoxetic acid-enhanced MRI, digital pathological whole-slide images, clinical records and long-term follow-up data. Cases were retrospectively collected from three Chinese tertiary hospitals and the public TCGA-LIHC database, excluding patients with incomplete imaging, pathological or follow-up information.

You may qualify if:

  • patients with pathologically confirmed hepatocellular carcinoma (HCC);
  • patients accepting curative surgical resection (SR) without preoperative adjuvant treatment;
  • MRI were performed two weeks before surgery.

You may not qualify if:

  • incomplete clinical information;
  • incomplete or suboptimal quality of preoperative MRI imaging data;
  • unavailable or poor-quality pathological whole slide images (WSIs);
  • incomplete follow-up data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

January 1, 2020

Primary Completion

December 31, 2024

Study Completion

January 1, 2026

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations