NCT06353126招募中2 期
A Prospective, Single Arm, Exploratory Study of Using Drug-eluting Beads Transarterial Chemoembolization Prior to SALT Liver Transplantation in the Treatment of Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recurrence-free survival (RFS)
研究概览
简要总结
The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to SALT (Sequential Adult Left Lateral Liver Transplantation) can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for SALT receive DEB-TACE 2 weeks prior to the surgery.
The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing SALT; 4) Adverse events related to DEB-TACE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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;
- •Subjects with viral hepatitis or cirrhosis are clinically diagnosed according to AASLD standards, which require a history of viral hepatitis or cirrhosis combined with imaging examinations (enhanced CT, MRI, second-generation ultrasound contrast agents). When the tumor diameter is greater than 2 cm, a diagnosis can be made if one imaging technique shows typical arterial phase rapid enhancement and rapid washout. If the diameter is 1-2 cm, two imaging techniques must confirm this, or one imaging technique confirms it and alpha-fetoprotein (AFP) is greater than 400 ng/ml. For subjects who cannot be clinically diagnosed, histological or cytological biopsy confirmation is required; original biopsy records can also be used for diagnosis.
- •Child-Pugh score A-B grade;
- •Tumor present in the right lobe of the liver;
- •Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7;
- •ECOG-PS score 0-1;
- •Scheduled for SALT as the primary treatment;
- •Signed informed consent form.
排除标准
- •Presence of definite cancer thrombi in the main portal vein, vena cava, or main bile duct;
- •Severe hepatic encephalopathy;
- •Coexisting pulmonary arterial hypertension (moderate to high risk, WHO Grade III-IV);
- •Severe contrast agent allergy;
- •Irreversible hepatic artery to hepatic vein shunt;
- •Special types of anatomical variations (Asan portal vein type III);
- •Extrahepatic metastatic tumors;
- •Concurrent active hepatitis or severe infection;
- •Tumor dissemination or distant metastasis, expected survival <3 months;
- •Renal dysfunction, creatinine >176.8 umol/L or creatinine clearance rate <30ml/min;
- •White blood cell count <3.0x109/L, platelet count <50x106/L, and unable to correct;
- •Inability to tolerate surgical anesthesia (severe infection, cardiopulmonary insufficiency, cerebrovascular disease);
- •Severe psychiatric illness;
- •Other reasons deemed unsuitable for participation by the investigator.
结局指标
主要结局
Recurrence-free survival (RFS)
时间窗: 2 years
the time from DEB-TACE treatment until tumor recurrence in the original site, transplanted liver, other tissues and organs, or death, whichever occurs first.
次要结局
- Overall survival (OS)(5 years)
- Pathological response rate (Pathological Response)(1 year)
- Proportion of patients completing living donor liver transplantation(at the time of the surgery)
- Adverse events related to DEB-TACE(from DEB-TACE to the surgery)
研究者
研究点 (1)
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