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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Objective Response Rate (ORR) after conversion therapy [Срок оценки: At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)]

Вторичные конечные точки (3)

• Association between baseline 3D-MRE parameters and pathological response [Срок оценки: Baseline (pre-treatment); surgical pathology if resection is performed]
• Surgical Conversion Rate [Срок оценки: Up to 6 months after conversion therapy initiation]
• Predictive accuracy (AUC) of baseline 3D-MRE parameters for treatment response [Срок оценки: Baseline through 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07716345 · XJTUSAH-MRE-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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