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Not yet recruitingNCT07716345Updated Jul 21, 2026

Inter-Individual Tumor Heterogeneity on 3D-MRE for Predicting Response to Conversion Therapy in Liver Cancer

An observational study in Hepato Cellular Carcinoma, Intrahepatic Bile Duct Carcinoma and Metastatic Hepatocellular Carcinoma, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
01

Study summary

How to predict which patients with initially unresectable liver cancer are more likely to respond to conversion therapy remains an important unresolved problem in guiding treatment strategy and surgical timing. Substantial variation exists among patients in their tumor response to the same conversion therapy regimen, and current pretreatment imaging assessment does not adequately capture this inter-individual variability. We hypothesize that baseline tumor viscoelastic parameters measured by three-dimensional magnetic resonance elastography (3D-MRE) differ substantially across patients, and that this inter-individual heterogeneity may be associated with differential response to conversion therapy. This study aims to prospectively evaluate the association between baseline 3D-MRE-derived tumor viscoelastic parameters and pathological response as well as surgical conversion outcomes across patients with liver cancer receiving conversion therapy.

02

Conditions studied

  • Hepato Cellular Carcinoma
  • Intrahepatic Bile Duct Carcinoma
  • Metastatic Hepatocellular Carcinoma
03

In context

Cholangiocarcinoma

824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.

This study's planned enrollment of 100 is below the median of 196 across 161 observational studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 70 studies on the registry; 16 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 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study will enroll adult patients with initially unresectable liver cancer, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastases (e.g., from colorectal cancer), who are planned to receive conversion therapy at the Second Affiliated Hospital of Xi'an Jiaotong University, with the treatment goal of achieving surgical resectability. Eligible patients will undergo 3D-MRE examinations prior to conversion therapy. Patients will be consecutively recruited from the hepatobiliary oncology multidisciplinary team (MDT) of the study center prior to initiation of conversion therapy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-75 years
  • Pathologically or radiologically confirmed diagnosis of initially unresectable liver cancer (hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver )
  • Planned to receive conversion therapy with the intent of achieving surgical resectability
  • class A or B liver function (for patients with primary liver cancer)
  • performance status 0-1
  • At least one per 1.1
  • Able to undergo 3D-MRE examination prior to conversion therapy
  • Provision of signed and dated

Exclusion criteria

Exclusion Criteria:

  • to MRI
  • class C liver function (for patients with primary liver cancer)
  • Uncontrolled ascites, hepatic encephalopathy, or variceal bleeding within 3 months prior to enrollment
  • Other concurrent active
  • Severe comorbidities precluding conversion therapy or surgery
  • Pregnant or breastfeeding women
  • Anticipated poor compliance with repeated MRE examinations or follow-up
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

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

Interventions

  • DeviceThree-Dimensional Magnetic Resonance Elastography

    Patients with initially unresectable liver cancer who are planned to receive conversion therapy will undergo a baseline three-dimensional magnetic resonance elastography (3D-MRE) examination prior to treatment initiation, in addition to standard-of-care evaluation. 3D-MRE will be used to quantify tumor viscoelastic parameters (including stiffness, storage modulus, loss modulus, and damping ratio) at baseline. These baseline imaging parameters will be compared across patients and analyzed for their association with subsequent pathological response and surgical conversion outcomes following conversion therapy. The examination does not alter the standard treatment regimen selected by the treating physician.

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) after conversion therapy

    Response evaluated according to RECIST 1.1 or mRECIST criteria based on imaging assessment after conversion therapy, analyzed in relation to baseline 3D-MRE parameters

    Time frame: At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)

Secondary outcomes

  1. Association between baseline 3D-MRE parameters and pathological response

    Correlation between baseline tumor stiffness (measured in kilopascals by three-dimensional magnetic resonance elastography) and pathological response status (major pathological response \[≤10% residual viable tumor\] vs. non-major pathological response, assessed by histopathological examination of the surgical specimen) in patients who undergo surgical resection following conversion therapy.

    Time frame: Baseline (pre-treatment); surgical pathology if resection is performed

  2. Surgical Conversion Rate

    Proportion of patients who successfully undergo surgical resection after conversion therapy

    Time frame: Up to 6 months after conversion therapy initiation

  3. Predictive accuracy (AUC) of baseline 3D-MRE parameters for treatment response

    Area under the receiver operating characteristic curve (AUC) for baseline 3D-MRE-derived tumor stiffness in predicting objective response (per RECIST 1.1 or mRECIST) to conversion therapy.

    Time frame: Baseline through 12 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07716345
Lead sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jul 21, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2029 (estimated)
Completion
Oct 1, 2030 (estimated)
Last update
Jul 21, 2026

Study contacts

Kai Qu
Contact
qukai001@xjtu.edu.cn
+8613609117104

Oversight

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

Not currently enrolling

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

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