Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Radiological response at 1 month according to mRECIST and ctDNA detection
研究概览
简要总结
Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE
详细描述
The incidence of hepatocellular carcinoma (HCC) has increased significantly over the past 30 years.
The majority of HCCs present at an intermediate stage, ineligible for a curative surgical approach and the reference treatment in this situation corresponds to a palliative locoregional treatment of Transarterial chemoembolization (TACE). This treatment modality can be repeated several times and the interval between each session as well as the modalities to evaluate the efficacy of this procedure remain poorly codified. This evaluation is currently based on imaging performed at one month (M1) (MRI and/or CT scan) more or less associated with the study of the variation of the alphafetoprotein level measured before (baseline) and after (M1) the treatment. However, these evaluation tools have many limitations and remain imperfect in predicting response to treatment.
In this context, liquid biopsy, which is experiencing significant growth in oncology, could be a promising tool. It is characterized by the detection of tumor elements in the bloodstream such as circulating tumor DNA (ctDNA). Several studies have successfully demonstrated the diagnostic or prognostic value of ctDNA in patients followed for HCC.
the aim of our study is to evaluate the impact of ctDNA detection in the follow-up of patients treated by TACE.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •HCC diagnosed on consensus radiological criteria in cirrhotic patients (EASL-EORTC 2012): helical CT or MRI with triple arterial, portal, and late acquisition. The diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared with non-tumor liver parenchyma) at the portal phase or late phase compared with non-tumor parenchyma.
- •Histologically diagnosed HCC in the absence of an imaging diagnosis
- •Patient with a first TACE (naive) or not, regardless of the number of previous procedures
- •Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.
- •Treatment decision validated by the digestive oncology staff.
- •Patient having read and understood the information letter and signed the informed consent.
- •Patient follow-up performed at the Charles Nicolle University Hospital in Rouen.
- •Exclusion Criteria :
- •Other active cancer or hematological malignancy, currently being treated
- •Patient not affiliated to the social security system
- •Pregnant woman or woman in labour or breastfeeding
- •Person deprived of liberty by an administrative or judicial decision
- •Person placed under court protection
排除标准
- 未提供
结局指标
主要结局
Radiological response at 1 month according to mRECIST and ctDNA detection
时间窗: 4 to 6 weeks
radiological response : mRECIST (progressive disease; stable disease, partial response, complete response) LIRADS (LR-TR Nonviable, LR-TR Equivocal, LR-TR Viable); ctDNA at 1 month detection (yes or no)
次要结局
- Progression-free survival and overall survival(4 to 6 weeks)