Observational Prospective Study on Chemoembolization Using Doxorubicin Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- tumor response
研究概览
简要总结
Hepatocellular carcinoma (HCC) is the fifth most common type of cancer in men and the seventh in women and is the third most common cause of death from cancer worldwide. The overall incidence of HCC remains high in developing countries and is steadily rising in most industrialized countries.
TACE with Doxorubicin-eluting beads (DEB-TACE) has recently been developed as a novel therapy option for HCC. In order to maximize its therapeutic efficacy, doxorubicin-loaded beads were developed to deliver higher doses of the chemotherapeutic agent and to prolong its permanence within the tumor. The comparison of efficacy and safety of TACE with drug-eluting microspheres in comparison with conventional TACE (cTACE) showed that response and time to progression in the group was significantly higher than that of the cTACE group. TACE with drug-eluting microspheres thus appears to be a feasible and promising approach to the treatment of HCC.
This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.
详细描述
This study's purpose is to assess treatment efficacy, survival rate and safety of TACE using drug-eluting microspheres loaded with doxorubicin for unresectable hepatocellular carcinoma.
Study Design: Prospective observational study . Primary objective: To collect data on tumor response after administration of drug-eluting microspheres that were preloaded with doxorubicin.
Secondary objectives: To collect data on survival rate, time to progression, tolerability of treatment, number of treatment required to achieve objective response and improvement of quality of life.
Treatment method:
Day -1 Doxorubicin at a dose of 35/50 mg/m2 has been charged onto 2 ml of microspheres at Pharmacy. It is suggested to dissolve Doxorubicin powder with 2 ml of contrast medium. The charging time of microspheres is at least 30 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with confirmed diagnosis of HCC
- •Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient rejects the above treatments
- •Multinodular or single nodular tumor more than 5cm
- •Hypervascular lesion showing contrast enhancement in the early stage after contrast media injection during CT or MRI.
- •At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
- •No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct
- •Eastern Cooperative Oncology Group performance status is 0 - 1
- •Proper blood, liver, renal, heart functionality
- •more than 18 years old
- •Expected survival more than 6 months
- •Prior written consent
排除标准
- •Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
- •Tumor burden involving more than 50% of the liver
- •History of biliary tract repair or endoscopic biliary tract treatment
- •Clinically important refractory ascites or pleural fluid
- •Any contraindications for hepatic embolization procedures
- •Any contraindication for doxorubicin administration
- •Contrast media allergy contraindicating angiography
- •Acute or active cardiac, hepatic or renal diseases
- •Pregnant, nursing or childbearing age women and men who are sexually active and don't want to or can't do contraception
结局指标
主要结局
tumor response
时间窗: 4 months
CT scan evaluation according to RECIST 1.1
次要结局
- survival rate(one year)
- time to progression(1 year)
研究者
Giammaria Fiorentini
Dr.
International Group of Endovascular Oncology