Inter-Individual Tumor Heterogeneity on 3D-MRE for Predicting Response to Conversion Therapy in Liver Cancer | NCT07716345

NCT07716345

Overview

NCT ID: NCT07716345
Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong UniversityOTHER
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
Brief Summary: 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.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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