NCT05072041招募中不适用
Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: a Prospective Comparative Study
Next Biomedical Co., Ltd.2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Incidence of postembolism syndrome
研究概览
简要总结
The purpose of this study was to prospectively collect clinical data from patients who underwent hepatic artery chemoembolization using microspheres with different degradation times (2 hours, 1 day, 2 weeks) based on standard treatment.
详细描述
This study is a prospective study, and the purpose of this study is to investigate and collect clinical information on the safety and efficacy of degradable microsphere for hepatic artery chemoembolization in hepatocellular carcinoma patients. The primary purpose of this study was to evaluate the incidence of postembolism syndrome and liver function impairment after hepatic artery chemoembolization, and the secondary purpose was to evaluate tumor treatment response and hepatic artery damage after 1 month of hepatic artery chemoembolization.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 19 to 79 years
- •Patient who signed Informed Consent Form
- •Patients diagnosed with hepatocellular carcinoma by American Association for the Study of Liver Diseases (AASLD) and at least one of the following methods i. Magnetic resonance imaging (MRI) with early augmentation and delayed excretion of at least one solid liver lesion greater than 1 ㎝.
- •ii. Contrast-enhanced computed tomography (CT) with early augmentation and delayed build-up of at least one solid liver lesion >1 ㎝.
- •iii. Lesions with inconclusive features require histological confirmation.
- •Patients should not be eligible for treatment by amputation or percutaneous resection or liver transplantation at the time of study enrollment.
- •i. Patients who are not suitable for ablation due to lesion location may be enrolled.
- •ii. Patients with recurrent hepatocellular carcinoma who are not suitable for amputation or resection may be enrolled.
- •Must be Child-Pugh A or B hepatocellular carcinoma, and must satisfy the following criteria.
- •i. Tumor lesion size from 1 ㎝ to 10 ㎝ ii. Number of tumors 1-7 iii. Physical activity European Cooperative Oncology Group (ECOG) ≤ 1 without vascular involvement
- •Patients who can be followed up until the end of the study and whose life expectancy is 6 months or longer
排除标准
- •Patients under the age of 19
- •Chronic kidney disease (CDK) grade 4 or 5 patients
- •Current or previous treatment with chemotherapy or radiation therapy or sorafenib or drug release chemoembolization (deTACE) after diagnosis of hepatocellular carcinoma
- •Pregnant, lactating, pre-menopausal and women not using effective contraceptive methods
- •Performance state European Cooperative Oncology Group (ECOG) > 1
- •Child-Poo Class C
- •Advanced hepatocellular carcinoma with vascular invasion or extrahepatic metastasis
- •Active Gastrointestinal Bleeding
- •Evidence of irreversible bleeding constitution
- •Encephalopathy that is not medically adequately controlled
- •Presence of ascites that is not medically controlled
- •Contraindications to Magnetic Resonance Imaging or Computed Tomography scan (e.g. metal implants)
- •Allergy to contrast media that cannot be managed by prevention
- •Contraindications to angiography
- •Contraindications to the administration of cisplatin anticancer drugs
- •Contraindications to hepatic artery embolization
- •Extensive context-to-systemic shunts
- •hepatofugal portal blood flow
- •Serum bilirubin > 3.0 ㎎/dL
- •Serum creatinine > 2.0 ㎎/dL
- •Other symptoms that your doctor has determined to be exclusive.
- •Irreversible blood clotting disorders
- •Others who are judged to be difficult for the principal investigator or principal investigator to conduct this clinical trial for other reasons
结局指标
主要结局
Incidence of postembolism syndrome
时间窗: 8 weeks
Nausea, vomiting, persistent pain, fever, and other
Incidence of liver function impairment
时间窗: 8 weeks
AFP, AST, ALT, BILI, GGT, BUN, and CREAT level
次要结局
- Hepatic artery damage(8 weeks)
- Tumor treatment response(8 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Taiwan ACE Beads for Hepatoma Embolization TherapyCancer of LiverNCT02825550National Cheng-Kung University Hospital13
已完成
1 期
Radioactive Holmium Microspheres for the Treatment of Liver MetastasesLiver MetastasisLiver TumorsNCT01031784UMC Utrecht15
进行中（未招募）
不适用
Percutaneous Holmium Injection in Pancreatic CancerPancreas CancerNCT05880472Radboud University Medical Center6
撤回
不适用
Monitoring of Patients Treated With Particle Therapy Using Positron-Emission-Tomography (PET): The MIRANDA StudyParticle TherapyNCT01528670University Hospital Heidelberg
招募中
不适用
The Efficacy and Safety of Drug Loaded Microsphere Bronchial Artery Chemoembolization (DEB-BACE) Combined With Anlotinib and Adebelimumab in the Third Line Treatment of Advanced NSCLC: a Prospective, Single Arm, Single Center, Exploratory Clinical StudyNon-Small Cell Lung CancerNCT06188650Ningbo Medical Center Lihuili Hospital30