Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Disease control rate (DCR)
研究概览
简要总结
To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.
详细描述
This is a prospective, multicenter, randomized controlled, non-inferiority design trial. Participants who meet the criteria will be randomly assigned into the experimental group or the control group，with a ratio of 1:1. In the experimental group the Thermosensitive Nanogel Embolic Agent will be used in the TACE procedure, while in the control group the Embosphere microspheres will be used. The primary endpoint is disease control rate of the target lesions at 1 month after the last TACE treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation;
- •Liver function status: Child-Pugh A or B
- •Eastern Cooperative Oncology Group score: 0-2 points;
- •With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;
- •Willing to participate in this trial and sign the informed consent.
排除标准
- •The target lesion has been embolized before or require combined with other treatment(s);
- •Diffuse or with extrahepatic metastasis;
- •Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);
- •Severe renal dysfunctions (creatinine clearance rate <30 ml/min);
- •Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times);
- •Main portal vein was completely occluded and no collateral blood supply was established;
- •With uncorrectable arteriovenous fistula or portal vein fistula;
- •Severe cachexia or hepatic encephalopathy;
- •With active infection;
- •Significant reductions in white blood cells or platelets (white blood cells<3.0x109/L, platelets<50x109/L) that cannot be corrected;
- •Pregnant or lactating women;
- •Difficulty in selective catheterization;
- •With the severe risk of non-target embolization;
- •Severely allergic to contrast agents or the embolic materials;
- •Participating in ongoing trial;
- •Unsuitable judged by the investigator.
结局指标
主要结局
Disease control rate (DCR)
时间窗: One month after the last TACE
Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST).
次要结局
- Success rate of target lesion embolization(One month after the last TACE)
- Objective response rate (ORR)(One month after the last TACE treatment)
- Disease control rate (DCR)(Three and six months after the first TACE)
- Equipment performance evaluation(One month after the first TACE)
- Adverse events(Up to 24 months)
研究者
Gao-jun Teng
Dean
Zhongda Hospital