The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Response to treatment
研究概览
简要总结
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.
PURPOSE: This phase II trial is studying the side effects of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
- Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma.
- Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres.
- Determine the toxic effects and adverse experiences associated with this therapy in these patients.
- Determine the survival time of patients treated with this therapy.
- Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy.
- Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy.
- Assess the quality of life of patients treated with this therapy.
OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time.
Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •Confirmed diagnosis of hepatocellular carcinoma (HCC)
- •Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level
- •No significant extrahepatic disease that may represent an imminent life-threatening outcome
- •No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •No hepatic dysfunction
- •Bilirubin ≤ 2.0 mg/dL
- •No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization
- •No pulmonary insufficiency
- •No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow
- •No contraindications to angiography
- •No contraindications to selective visceral catheterization
- •No other condition or cormorbidity that would preclude study treatment
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 30 days after study
- •PRIOR CONCURRENT THERAPY:
- •At least 1 month since prior chemotherapy, radiotherapy, or surgery
- •No other concurrent investigational agents or anticancer therapy for HCC
排除标准
- 未提供
结局指标
主要结局
Response to treatment
Survival time from treatment
Adverse experiences
次要结局
未报告次要终点
研究者
Allan Tsung
Associate Professor
University of Pittsburgh