NCT05770635Enrolling By Invitation不适用
A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Polyvinyl Alcohol Embolization Microspheres for Transarterial Chemoembolization of Primary Liver Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) 1 month after the last TACE -mRECIST evaluation
研究概览
简要总结
To evaluate the safety and efficacy of polyvinyl alcohol embolization microspheres developed and manufactured by Shanghai Huihe Medical Technology Co., LTD. (hereinafter referred to as Huihe Medical) for transarterial chemoembolization of primary liver cancer using a prospective, multi-center, randomized controlled method
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old; age ≤85 years old; regardless of gender
- •Patients with CNLC Ib, IIa, IIb, IIIa who need transarterial chemoembolization (TACE) therapy and are not suitable for or refuse surgical resection, liver transplantation, and ablation, and patients with stage IIIb primary liver cancer who are expected to benefit from TACE therapy to control the growth of intrahepatic tumors;
- •Child-Pugh A or B (less than 10 points);
- •performance status (PS) score of ECOG 0~2;
- •The patient had at least one measurable tumor lesion without embolization (maximum diameter of the target lesion ≤10cm);
- •Those who agree to participate in the clinical trial and voluntarily sign the informed consent;
排除标准
- •Patients whose target lesions had received embolization therapy, whose target lesions had received other local treatments besides TACE (including but not limited to surgery, radiotherapy, hepatic arterial perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) within 1 month, or who had received first TACE therapy for target lesions combined with ablation/radiotherapy after inclusion;
- •The proportion of tumor in total liver volume was ≥70%;
- •Patients with distant extensive metastasis or other malignant tumors;
- •The expected survival time is less than 3 months;
- •Cachexia or multiple organ failure;
- •Severe liver dysfunction (Child-Pugh grade C), including jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome;
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal or >250U/L, and ≥2 times the upper limit of normal after 1 week of liver protection and antiviral treatment;
- •Renal dysfunction: patients with serum creatinine > 2mg/dL;
- •Blood leukocytes and platelets decreased significantly, leukocytes < 3.0×109/L, platelets < 50×109/L (except patients with hyperplenism and chemotherapy myelosuppression);
- •Bleeding and thrombotic tendency: patients with known hereditary or acquired bleeding and thrombotic tendency (e.g., hemophiliacs, uncorrectable coagulation disorders, thrombocytopenia, hyperplenism, etc.), active peptic ulcer or gastrointestinal bleeding within 30 days; Arteriovenous thrombosis occurred in the past 6 months (until enrollment);
- •Patients with active hepatitis or severe infection who cannot be treated with TACE simultaneously;
- •Patients with complete obstruction of the main portal vein and unable to restore portal blood flow through compensatory collateral branches of the portal vein;
- •The target focal blood supply arteries cannot be treated with TACE or have the risk of embolization (vascular access endangers normal areas, arteriovenous fistula, portal fistula, etc.);
- •Subjects who predicted that the target lesion would require more than three TAces; Uncontrolled diabetes mellitus;
- •People with known severe allergy to contrast agents, iodine contrast agents or embolic materials;
- •Pregnant/lactating women, or those who plan to give birth;
- •Patients who are participating in clinical trials of other drugs or devices and have not been in the group or have been in the group for less than 1 month;
- •Persons without the ability to make independent decisions or with mental illness;
- •Other patients deemed unsuitable for this clinical trial by the investigator;
结局指标
主要结局
Objective response rate (ORR) 1 month after the last TACE -mRECIST evaluation
时间窗: 1 month after the last TACE -mRECIST evaluation
Target lesions of subjects were treated with TACE for 1-3 times as needed, and the last evaluation of target lesions before enrollment was used as baseline tumor evaluation. One month after the last TACE, all subjects underwent plain CT and enhanced MRI examinations, which were compared with the baseline of target lesions. The efficacy was evaluated according to the mRECIST (Modified Response Evaluation Criteria in Solid Tumors)for the treatment of solid tumors in target foci. For example, multiple tumor foci were embolized at the same time, and the two largest target foci were selected as the evaluation foci:
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
DEBIRI Combined With Chemotherapy and Bevacizumab in the Treatment of Unresectable Colorectal Cancer Liver MetastasesColorectal NeoplasmsNCT06177288Fudan University39
招募中
不适用
Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous MalformationsIntracranial Arteriovenous MalformationsNCT05058482Suzhou Hengruihongyuan Medical Technology Co. LTD116
已完成
不适用
Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial AneurysmsIntracranial AneurysmsNCT03550638Zhuhai Tonbridge Medical Tech. Co., Ltd.256
招募中
不适用
ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent RestenosisIntracranial AtherosclerosisStrokeNCT04627870Acotec Scientific Co., Ltd20
尚未招募
不适用
Aneurysm Embolization System for Intracranial AneurysmsRuptured Cerebral AneurysmNCT06485492Jiangsu CED Medtech Co., Ltd150