A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Response to Treatment by RECIST Criteria
研究概览
简要总结
The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.
详细描述
Biocompatibles LC Bead (also known as DC Bead in Asia & Europe) microspheres are preformed soft, deformable microspheres that may be loaded with doxorubicin and used to occlude blood flow to a cancerous tumour. LC Bead microspheres consist of a macromere derived from PVA. The fully polymerized microsphere is approximately 90% water and is compressible to approximately 30% by diameter. The microspheres can be delivered through conventional catheters (4-5Fr) or micro-catheters in the 2-3Fr range. These microspheres, like all agents used for arterial embolization, are mixed with radiographic contrast prior to administration in order to allow for fluoroscopic control of the embolization procedure.
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
- Single (Participant)
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
- •Patient with a confirmed diagnosis of HCC according to EASL criteria for diagnosis; who is not a surgical resection candidate, or refuses surgery
- •Patient must be 18 years of age or older
- •Patient must be Okuda stage I or II
- •Patient must have an ECOG performance status of 0 or 1
- •No prior chemotherapy or biotherapy within 4 weeks of scheduled embolization, with all toxicities, if any, resolved to grade < than or = to 1
- •Patient must have the following laboratory values confirmed within 14 days of registration:
- •Creatinine ≤ than or = to 2.0 the institution ULN
- •Platelets ≥ than or = to 50,000/mm3
- •INR ≤ than or = to 2.0 for patients who are not on Coumadin
- •aPTT < or = to twice control
- •Bilirubin < 3 mg/dl
- •WBC > 3000 cells/mm3
- •ANC > 1500 cells/mm3
- •Negative serum pregnancy test (Female of childbearing potential only)
排除标准
- •Patient has another primary tumor, with the exception of conventional basal cell CA, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease
- •Women who are pregnant or lactating
- •Patient previously treated with doxorubicin
- •Contraindication to angiography/embolization including: patients who cannot receive contrast 1.Severe allergic reaction to contrast despite pre-medication,
- •poor renal function; 3.Lack of arterial access (eg femoral artery occlusion);
- •other, based on judgment of the investigator
- •Patient has already undergone hepatic arterial embolization for the hepatocellular cancer for which they are currently being evaluated
- •Patient has received prior radiotherapy for the hepatocellular cancer for which they are currently being evaluated
- •Patient has had previous local-regional treatment of the current target tumor volume
- •Patient who cannot have CT scan
- •Patient at very high risk for post-embolization hepatic failure:
- •Child's C cirrhosis,
- •> 75% liver replaced by tumor
- •Cardiac exclusion for:
- •Myocardial infarction within 90 days of study,
- •uncontrolled arrhythmia,
- •LVEF < 50% for patients randomized to receive LC Bead
- •Patients with tumors exhibiting characteristics considered contra-indications to particle embolization, including:
- •collateral vessel pathways potentially endangering normal territories during embolization,
- •arteries supplying tumor not large enough to accept LC Bead or Bead Block,
- •Presence of arterial to systemic venous shunts,
- •Presence of arterial to pulmonary vascular shunts
结局指标
主要结局
Response to Treatment by RECIST Criteria
时间窗: 2 to 3 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Number of Participants Evaluated for Toxicity(1 year)
- Overall Survival(1 year)
- Progression Free Survival(1 year)