NCT00503867终止不适用
A Pilot Study of Yttrium-90 Microspheres (SIR-Spheres®) Therapy for the Treatment of Unresectable Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Number of Participants With Adverse Events Grade 3 or Higher
研究概览
简要总结
The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.
详细描述
This study is a multi-institutional, non-randomized pilot study that aims to assess the safety and toxicity of hepatic arterial radioembolization using SIR-Spheres yttrium-90 microspheres (SIR-Spheres microspheres) in the treatment of patients with unresectable primary hepatocellular carcinoma (HCC). The study aims to recruit 40 patients over a period of 24 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have a confirmed diagnosis of HCC.
- •at least 18 years of age.
- •must have a confirmed diagnosis of HCC either by histological confirmation or, in a subject who exhibits a vascular liver mass in the presence of radiographically apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 International Units/milliliter (UI/ml).
- •must present HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation due to its size, extent or presence of cirrhosis.
- •must present measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 10 mm with spiral CT scan or greater than or equal to 20 mm using conventional techniques (CT, MRI).
- •must present with a whole-liver tumor burden of greater than or equal to 15% and less than or equal to 70%
- •must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- •must have normal organ and marrow function
- •Exclusion criteria:
- •Includes both the listed contraindications to SIR-Spheres® and the exclusion criteria specific to the setting of this investigational study:
- •hepatic artery directed therapy within the previous 6 months.
- •chemotherapy within the previous 4 weeks
- •have not recovered from adverse events due to agents administered previously
- •Prior external hepatic radiation therapy for HCC, more than two prior systemic chemotherapy regimes for HCC or any other concomitant therapy for HCC
- •Currently receiving any other investigational agents for the treatment of their cancer.
- •Any extra-hepatic metastases other than metastatic disease found in the lung, bone and/or abdominal lymph nodes that are not otherwise life limiting.
- •Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
- •Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- •Any of the following contraindications to angiography and selective visceral catheterization:
- •Bleeding diathesis
- •Severe peripheral vascular disease
- •Portal hypertension with hepatofugal flow
- •Female subjects who are pregnant or currently breastfeeding.
- •Refusal or inability to use effective means of contraception in men or women of childbearing potential.
- •Current enrollment in any other investigational drug or device study.
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Adverse Events Grade 3 or Higher
时间窗: From date of enrollment until the date of death from any cause assessed up 24 weeks.
Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.
次要结局
- Overall Survival(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.)
- Tumor Response Rate(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.)
- Time to Disease Progression(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.)
- Change From Baseline in Health-related Quality of Life(52 weeks)
研究者
研究点 (8)
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