Intrahepatic Cholangiocarcinoma (Icc)NCT07479264
A Study on Intratumoral Fibrosis and α-SMA Expression in Intrahepatic Cholangiocarcinoma
An observational study of Intrahepatic Cholangiocarcinoma (Icc), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (Icc)
- How many people
- 169 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who underwent radical resection of liver tumors in our center and obtained surgical specimens;
- ICC was diagnosed by postoperative pathology
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: MRI-Based Radiomics and Machine Learning for Preoperative Assessment of Intratumoral Fibrosis and α-Smooth Muscle Actin Expression in Intrahepatic Cholangiocarcinoma
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.
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Being tested
- No Interventions
- Keywords
- Intrahepatic cholangiocarcinoma, MRI, Intratumoral fibrosis, α-SMA, Prognosis
- Medical subject headings
- Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intratumoral high-fibrosis group | Not described Receives: Other: No Interventions | |
| intratumoral low-fibrosis group | Not described Receives: Other: No Interventions | |
| α-SMA high-expression group | Not described Receives: Other: No Interventions | |
| α-SMA low-expression | Not described Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effects
5-year overall survival (OS)
Measured: From the time of the patient's surgery to the end of the 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jan 2018
- Primary completion17 Jan 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholangiocarcinoma (Icc)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Danyang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479264
- Sponsor's protocol ID
- SYSUFAH20260311
- Other IDs
- 82471948
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All primary data are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Based Radiomics and Machine Learning for Preoperative Assessment of Intratumoral Fibrosis and α-Smooth Muscle Actin Expression in Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT07479264
- Acronym / sponsor ID
- SYSUFAH20260311
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Keywords
- Intrahepatic cholangiocarcinoma, MRI, Intratumoral fibrosis, α-SMA, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who underwent radical resection of liver tumors in our center and obtained surgical specimens;
- ICC was diagnosed by postoperative pathology
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsOnly the degree of intratumoral fibrosis and the expression of α-SMA in the postoperative pathological specimens of ICC patients were observed, without intervention measures. | Other | intratumoral high-fibrosis group, intratumoral low-fibrosis group, α-SMA high-expression group, α-SMA low-expression |
Primary outcome
Treatment Effects
Time frame: From the time of the patient's surgery to the end of the 5-year follow-up
5-year overall survival (OS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided. All primary data are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholangiocarcinoma (Icc), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Effects (time frame: From the time of the patient's surgery to the end of the 5-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.