Clinical trial · Observational
Inter-Individual Tumor Heterogeneity on 3D-MRE for Predicting Response to Conversion Therapy in Liver Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepato Cellular Carcinoma | Cholangiocarcinoma | PROBABILISTIC | 0.70 |
| Intrahepatic Bile Duct Carcinoma | Intrahepatic Cholangiocarcinoma | ALIAS | 0.90 |
| Metastatic Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Three-Dimensional Magnetic Resonance Elastography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective Response Rate (ORR) after conversion therapy
- timeFrame
- At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)
- description
- 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 (3)
- measure
- Association between baseline 3D-MRE parameters and pathological response
- timeFrame
- Baseline (pre-treatment); surgical pathology if resection is performed
- description
- 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.
- measure
- Surgical Conversion Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
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