A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Occlusafe® Assisted Microwave Alone or in Combination With DEB-TACE Compared to Microwave in Combination With DEB-TACE in the Treatment of Intermediate Size HCC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of participants with complete response according to mRECIST one month after the procedure
研究概览
简要总结
The goal of this Interventional Study is to compare the efficacy profile and safety of three treatments in patients with HCC nodule.
Patients will be randomly divided in three arms:
- Occlusafe assisted MWA+ DEB-TACE
- Occlusafe assisted MWA
- MWA+ DEB-TACE
The primary objectives are evaluate the safety of the three treatments; evaluate the effectiveness of treatments one month after the procedure (defined as complete ablation of macroscopic tumor at one month of follow-up), verifying the possible superiority of arm 1 and arm 2 compared to arm 3.
The secondary objective is: time to local disease recurrence.
详细描述
Microwave ablation (MW) is based on the production of heating by friction given by the oscillation of water molecules.
The delivery of drug-releasing microspheres (DEB-TACE) at the same time as microwave ablation, could promote the arrest of tumor growth.
After positioning and inflating the Occlusafe® balloon in the artery that connects to the HCC nodule, the blood flow tends to go preferentially to the HCC nodule compared to the healthy liver. In addition, the flow is slowed down inside the nodule due to the drop in the resistance of the tumor arteries, resulting in stagnation of intranodular blood. The increase in the water content in the tumor area, after using the Occlusafe® balloon microcatheter, could increase the ability of microwave ablation to cover larger volumes in a shorter time.
In parallel, the delivery of drug-releasing microspheres (DEB-TACE) is provided both with inflation with Occlusafe® and without. This will allow to verify if a better treatment efficiency can be achieved in the peripheral ablation areas.
The study also includes a third control arm, consisting of ablation and DEB-TACE without Occlusafe®.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age;
- •any ethnicity;
- •Patient with almost one HCC 3-5cm with biopsy according to EASL/EORTC guidelines;
- •Patient is not candidate for liver resection;
- •Child Pugh A;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0;
- •Willing to sign an informed consent form, indicating awareness of the investigational nature of this study that is in keeping with the policies of the institution.
排除标准
- •Have previously received therapeutic treatment for HCC outside the study protocol;
- •Have extrahepatic metastasis;
- •Have portal or hepatic vein tumor invasion/thrombosis;
- •Baseline laboratories:
- •Platelet count < 50,000/mm3; INR > 1,5;
- •Baseline Chemistry: Serum creatinine ≥ 2.0 mg/dL or calculated creatinine clearance (CrCl) ≤30.0 mL/min; Serum bilirubin > 3.0 mg/dL;
- •Are pregnant or breast-feeding. In women of childbearing potential, a negative serum pregnancy test is required prior to study treatment;
- •Have contraindications to receiving doxorubicin;
- •Have other concurrent malignancy (subjects with treated squamous cell carcinoma of the skin or basal cell carcinoma of the skin may be included), evidence of extrahepatic cancer from their primary malignancy, or ongoing, medically significant active infection.
结局指标
主要结局
Number of participants with complete response according to mRECIST one month after the procedure
时间窗: one month
Number of participants with complete response according to mRECIST one month after the procedure, verifying the possible superiority of arm 1 and arm 2 compared to arm 3.
Number of Participants With Treatment-Related Adverse Events as Assessed by CIRSE classification of complications
时间窗: 30 days
Evaluate the safety of the three treatments by CIRSE classification
次要结局
- Time to local disease recurrence(1 month, 4 months, 7 months, 10 months, 13 months)
研究者
Laura Crocetti
Principal Investigator
University of Pisa