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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hepato Cellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Intrahepatic Bile Duct Carcinoma Liver Diseases Liver Neoplasms Metastatic Hepatocellular Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Three-Dimensional Magnetic Resonance Elastography

Device

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.

Primary outcomes

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

Secondary outcomes

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.
Surgical Conversion Rate

Time frame: Up to 6 months after conversion therapy initiation

Proportion of patients who successfully undergo surgical resection after conversion therapy
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Qu

CONTACT

[email protected]

+8613609117104

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Jul 21, 2026
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting