Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.
PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works in treating patients with liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
- Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular carcinoma.
OUTLINE: This is a pilot study.
Patients undergo catheterization of the hepatic artery followed by chemoembolization comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the target hepatic artery. Patients may receive up to 3 chemoembolization treatments.
After completion of study treatment, patients are followed at 1 month, every 2 months for 1 year, and then every 3 months during year 2.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging classification
- •No advanced disease, as defined by any of the following:
- •Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the following:
- •Vascular invasion, including segmental portal obstruction
- •Extrahepatic spread
- •Cancer-related symptoms (PST of 1-2)
- •BCLC class D disease, as defined by the following:
- •Okuda stage III disease
- •World Health Organization (WHO) performance status 3 or 4
- •Diffuse HCC, defined as massive ill-defined tumor involvement
- •Child-Pugh Class C
- •Not eligible for radical therapies (e.g., resection, liver transplantation, or percutaneous therapies)
- •No significant liver decompensation
- •Preserved liver function (Child-Pugh class A-B)
- •No ascites (trace ascites allowed)
- •No other active primary tumor
- •Arteries supplying the lesion must be large enough to accept GelSpheres™ beads
- •PATIENT CHARACTERISTICS:
- •Bilirubin ≤ 3 mg/dL
- •Albumin > 2.0 g/dL
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)
- •No active gastrointestinal bleeding
- •No encephalopathy
- •No contraindication to hepatic embolization procedures, as indicated by any of the following:
- •Porto-systemic shunt
- •Hepatofugal blood flow
- •Platelet count < 50,000/mm^3
- •International normalized ratio (INR) ≥ 1.8
- •Partial thromboplastin time (PTT) ≥ 39 seconds
- •Renal failure
- •Severe atheromatosis
- •No contraindication to doxorubicin hydrochloride administration, as indicated by any of the following:
- •Bilirubin > 5 mg/dL
- •White blood cell (WBC) < 1,500/mm^3
- •Ejection fraction < 50% by isotopic ventriculography or echocardiography
- •Not pregnant
- •No known allergy to contrast media
- •No intolerance to occlusion procedures
- •No vascular anatomy or bleeding that would preclude catheter placement or emboli injection, as indicated by any of the following:
- •Active or risk of hemorrhage
- •Patent extra-to-intracranial anastomoses or shunts
- •End arteries leading directly to the cranial nerves
- •Feeding arteries smaller than distal branches from which they emerge
- •Collateral vessel pathways that would potentially endanger normal territories during embolization
- •PRIOR CONCURRENT THERAPY:
- •No prior anticancer therapy for HCC
排除标准
- 未提供
研究组 & 干预措施
Drug-eluting bead transarterial chemoembolization (DEB-TACE)
Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.
干预措施: Drug-eluting beads loaded with doxorubicin hydrochloride (Device)
结局指标
主要结局
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: 6 months
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, and at 6 months post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Efficacy - Overall Survival
时间窗: 2 Years
Presented are the counts of patients that have survived up to 2 years.
Safety
时间窗: 6 months
Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.
Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria
时间窗: 1 month
Efficacy as assessed by radiographic tumor response using EASL criteria at baseline and at 1 month post-TACE Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions.
Safety
时间窗: 1 month
Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: 1 month
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 1 month post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Efficacy - Overall Survival
时间窗: 1 Year
Presented are the counts of patients that have survived up to 1 year.
次要结局
未报告次要终点