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

July 20, 2026 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

A Prospective Study on Inter-Individual Tumor Heterogeneity Assessed by Three-Dimensional Magnetic Resonance Elastography for Predicting Response to Conversion Therapy in Patients With Liver Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication to MRI
  • Child-Pugh 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 malignancy
  • Severe comorbidities precluding conversion therapy or surgery
  • Pregnant or breastfeeding women
  • Anticipated poor compliance with repeated MRE examinations or follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) after conversion therapy
Time Frame: At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)
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
At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between baseline 3D-MRE parameters and pathological response
Time Frame: Baseline (pre-treatment); surgical pathology if resection is performed
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.
Baseline (pre-treatment); surgical pathology if resection is performed
Surgical Conversion Rate
Time Frame: Up to 6 months after conversion therapy initiation
Proportion of patients who successfully undergo surgical resection after conversion therapy
Up to 6 months after conversion therapy initiation
Predictive accuracy (AUC) of baseline 3D-MRE parameters for treatment response
Time Frame: Baseline through 12 weeks
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.
Baseline through 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTUSAH-MRE-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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