NCT05889949进行中（未招募）不适用
Prediction of Microvascular Invasion by Radiomics Based on Pre-treatment Magnetic Resonance Imaging (MRI) for Guiding Treatment of Barcelona Clinic Liver Cancer (BCLC) Stage B Hepatocellular Carcinoma (HCC): A Prospective Cohort Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The goal of this observational study is to explore the role of prediction of microvascular invasion by radiomics based on pre-treatment magnetic resonance imaging for guiding treatment of Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma.
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;
- •BCLC stage B HCC;
- •Received no previous anti-cancer treatment;
- •At least 1 measurable intrahepatic lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;
- •Adequate hematological, liver, renal function:
- •absolute neutrophil count ≥ 1.5×109/L;
- •platelet count ≥ 100×109/L;
- •hemoglobin concentration ≥ 90 g/L;
- •albumin ≥ 28 g/L;
- •total bilirubin < 1.5 times the upper limit of normal;
- •alanine aminotransferase and aspartate aminotransferase < 5 times the upper limit of normal;
- •blood urea nitrogen and serum creatinine concentration < 1.5 times the upper limit of the normal range or less and creatinine clearance rate ≥ 45 mL/min;
- •Life expectancy of at least 3 months.
排除标准
- •Acute or chronic active hepatitis B (HBV) or C (HCV) infection with HBV-DNA > 2000 IU/ml or 104 copies/ml; hepatitis C virus RNA > 103 copies/ml; HBsAg and anti-HCV antibody positive at the same time. Those who are below the above criteria after nucleoside based antiviral therapy may be enrolled;
- •Life-threatening bleeding event within the past 3 months, including the need for blood transfusion, surgical or local treatment, or continuous medication;
- •History of previous arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary artery embolism, deep vein thrombosis, or any other serious thromboembolism;
- •Use of aspirin (>325 mg/day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel for 10 consecutive days within 2 weeks prior to enrollment;
- •Uncontrolled hypertension, systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy;
- •Symptomatic congestive heart failure (New York Heart Association class II-IV); Symptomatic or poorly controlled arrhythmias; History of congenital long QT syndrome or corrected QT (QTc) > 500 ms at screening;
- •Diagnosis of other malignant tumors within 5 years prior to enrollment;
- •Pregnant or lactating women or subjects planning to have a baby during the study period;
- •Accompanied with other uncontrolled co-morbidities;
- •Co-infection with HIV, known syphilis infection requiring treatment.
研究组 & 干预措施
TACE+MKIs
干预措施: Sorafenib (Drug)
TACE+MKIs
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
OS was defined as the interval from the date of enrollment to the date of death due to any cause or last follow-up.
Progression-Free Survival (PFS)
时间窗: From the date of enrollment to the date of disease progression or the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
PFS was defined as the interval from the date of enrollment to the date of disease progression or the date of death due to any cause or last follow-up, whichever occurred first.
次要结局
- Tumor response(From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months)
- Adverse events(From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months)
研究者
Zhen-Wei Peng
Professor
Sun Yat-sen University
研究点 (1)
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