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.
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)
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
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.
Cohort
Prospective
Three-Dimensional Magnetic Resonance Elastography
DevicePatients 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.
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
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.
Surgical Conversion Rate
Proportion of patients who successfully undergo surgical resection after conversion therapy
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.
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