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CompletedNCT07479264Updated Mar 18, 2026

A Study on Intratumoral Fibrosis and α-SMA Expression in Intrahepatic Cholangiocarcinoma

An observational study in Intrahepatic Cholangiocarcinoma (Icc), sponsored by First Affiliated Hospital, Sun Yat-Sen University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
169
Sex
All
01

Study summary

The aim of this observational study was to understand the prognostic imaging of the degree of intratumoral fibrosis and intratumoral α-SMA levels in patients with intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are:

Whether the degree of intratumoral fibrosis and the level of intratumoral α-SMA affect the overall survival and progression-free survival of ICC patients.

Participants will be surveyed for survival and tumor recurrence up to 5 years after surgery.

Read the detailed description

Intrahepatic cholangiocarcinoma (ICC), which originates from the proximal secondary bile duct in the liver parenchyma (based on the direction of bile flow), is the second most common type of primary liver cancer after hepatocellular carcinoma, accounting for 10-20% of all primary liver cancers. In recent years, the incidence and mortality of ICC have been increasing in most regions of the world. α-SMA-positive CAFs in ICC may aggravate tumor progression and reduce survival time, which is a significant prognostic indicator. However, the evaluation of α-SMA expression level in previous studies mostly relied on subjective evaluation by pathologists after visual observation, and there was a lack of quantitative indicators. In addition, there are differences in the effect of intratumoral fibrosis on the prognosis of ICC, and there may be an interactive relationship between the expression of α-SMA and intratumoral fibrosis. The effect of intratumoral α-SMA expression level and fibrosis on the prognosis of ICC still deserves further exploration. Therefore, the aim of this study is to investigate the relationship between the expression level of α-SMA and the degree of fibrosis in ICC and Progression-free survival (PFS) and Overall survival (OS) by survival analysis. To determine the expression level of α-SMA and the risk degree of fibrosis in ICC.

02

Conditions studied

  • Intrahepatic Cholangiocarcinoma (Icc)

Keywords

  • Intrahepatic cholangiocarcinoma
  • MRI
  • Intratumoral fibrosis
  • α-SMA
  • Prognosis
03

In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

This study's enrollment of 169 is below the median of 196 across 176 observational studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with single ICC who underwent radical partial hepatectomy in our hospital from January 2018 to January 2024 were retrospectively enrolled in this study.

Inclusion criteria

  • Patients who underwent radical resection of liver tumors in our center and obtained surgical specimens;
  • ICC was diagnosed by postoperative pathology

Exclusion criteria

Exclusion Criteria:

  • Patients had received radiotherapy, chemotherapy, intervention and other treatments for liver tumors before surgery
  • The tumor sections could not be obtained due to the loss of wax blocks or most of the defects of pathological specimens
  • No upper abdominal Gd-EOB-DTPA-enhanced MRI examination in our center within one month before surgery
  • Poor image quality or incomplete image data
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
169 participants (actual)
Patient registry
No

Groups and cohorts

  • intratumoral high-fibrosis group

    Other: No Interventions

  • intratumoral low-fibrosis group

    Other: No Interventions

  • α-SMA high-expression group

    Other: No Interventions

  • α-SMA low-expression

    Other: No Interventions

Interventions

  • OtherNo Interventions

    Only the degree of intratumoral fibrosis and the expression of α-SMA in the postoperative pathological specimens of ICC patients were observed, without intervention measures.

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What researchers measure

Primary outcomes

  1. Treatment Effects

    5-year overall survival (OS)

    Time frame: From the time of the patient's surgery to the end of the 5-year follow-up

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Study locations

1 site
  • The First Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
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References and documents

Individual participant data

Plan to share: Undecided — All primary data are available from the corresponding author upon reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 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
NCT07479264
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible party
Xu Danyang (Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Mar 18, 2026
Start date
Jan 1, 2018
Primary completion
Jan 17, 2025
Completion
May 1, 2025
Last update
Mar 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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