A Single-arm Trial of Transcatheter Arterial Chemoembolization With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 10
- 主要终点
- Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
研究概览
简要总结
A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
详细描述
It is a prospective, single-arm, multicenter study. The primary effectiveness endpoint for this clinical trial is 6-month overall objective tumor response (ORR).
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
- •Subject is able to provide informed consent and must sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent Form.
- •Male or female of age ≥18 and ≤75 years.
- •Confirmed diagnosis of HCC according to the diagnostic criteria included in the management guideline issued by China's Ministry of Health in
- •HCC is diagnosed for the first time or recurrence of tumor after surgical or ablation treatment.
- •Single tumor less than 7cm in diameter or multiple tumors with maximum 3 lesions with >1cm in diameter, individual diameter <7cm and less than 10cm in total diameter.
- •no previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) for HCC
- •Preserved liver function (Child-Pugh A or B7).
- •ECOG Performance Status 0 or 1.
排除标准
- •Presence of vascular invasion or extra-hepatic spread of disease, or diffuse HCC, defined as >50% liver involvement , or arteriovenuous fistula
- •Macrovascular invasion of main or primary branches of portal vein at entry into the study
- •Any contraindication for TACE treatment
- •Any contraindication for Epirubicin administration
- •Advanced liver disease (bilirubin levels >2 mg/dl, AST or ALT >5 times upper limit of normal)
- •Renal failure or insufficient renal function (Creatinine levels >2 mg/dl)
- •Subject unable to receive MRI examination
- •Pregnant or breast feeding woman, or plan to become pregnant during treatment or within 12 months of treatment
- •couldn't commit reliable birth control measures during treatment or within 12 months of treatment
- •Subject is participating other investigational drug or device clinical trial within 30 days of signing the informed consent
- •Subject is not suitable to participate in the study as judged by investigator
结局指标
主要结局
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging)
时间窗: At 6 months
The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR. 1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart.
次要结局
- Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months(At 12 months)
- Number of Participants With Objective Tumor Response at 30-day(At 1month)
- Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months(from first TACE to 12 months)
- Kaplan-Meier Analyses the Percent of Participants for Overall Survival(from first TACE to 12 months)
- Number of Adverse Events Relate to Study Device in 12 Months Post Procedure(in 12 months)
- Number of Participants With Objective Tumor Response at 3 Months(At 3 months)
- Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread(At 12 month)