Inter-Individual Tumor Heterogeneity on 3D-MRE for Predicting Response to Conversion Therapy in Liver Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Three-Dimensional Magnetic Resonance Elastography.
- Who it may be relevant to
- Registry conditions: Hepato Cellular Carcinoma, Intrahepatic Bile Duct Carcinoma, Metastatic Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Device Three-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 the
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- Association between baseline 3D-MRE parameters and pathological response [Time frame: Baseline (pre-treatment); surgical pathology if resection is performed]
- Surgical Conversion Rate [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07716345 · XJTUSAH-MRE-003