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

N/ANot Yet RecruitingNCT07716345

Second Affiliated Hospital of Xi'an Jiaotong University100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Hepato Cellular Carcinoma Intrahepatic Bile Duct Carcinoma Metastatic Hepatocellular Carcinoma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)

Secondary Outcomes

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.

Time frame: Baseline (pre-treatment); surgical pathology if resection is performed

Surgical Conversion Rate

Proportion of patients who successfully undergo surgical resection after conversion therapy

Time frame: Up to 6 months after conversion therapy initiation

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.

Time frame: Baseline through 12 weeks