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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Objective Response Rate (ORR) after conversion therapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Objective Response Rate (ORR) after conversion therapy
时间窗: At the time of post-conversion therapy imaging evaluation (approximately 8-12 weeks after treatment initiation)
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
次要结局
- Association between baseline 3D-MRE parameters and pathological response(Baseline (pre-treatment); surgical pathology if resection is performed)
- Surgical Conversion Rate(Up to 6 months after conversion therapy initiation)
- Predictive accuracy (AUC) of baseline 3D-MRE parameters for treatment response(Baseline through 12 weeks)