NCT02304445撤回不适用
Trans-Arterial Chemo-Embolization (TACE) Vs. TACE Plus Stereotactic Body Radiosurgery (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)
Juan Sanabria, MD0 个研究点开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Tumor response rate
研究概览
简要总结
This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma (Barcelona Stage B or C)
- •Treatment with Stereotactic Body Radiosurgery can occur within 6 weeks of enrollment
- •Age ≥ 18 years and ≤ 70 years
- •Eastern Cooperative Oncology Group Performance status ≤ 2
- •Patient has a) Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board
- •Hemoglobin > 10.0 g/dL
- •Total bilirubin > 3.0 mg/dL
- •AST (SGOT) ≤ 3x institutional upper limit of normal
- •ALT (SGPT) ≤ 3x institutional upper limit of normal
- •Absolute neutrophil count ≥ 1,500/μl
- •Platelet count ≥ 50,000/μl (may be post-transfusion if clinically indicated)
- •Aggregate maximal dimension of liver tumors ≤ 8 cm
- •Cirrhosis classified as Child Pugh Class A or B (score ≤ 7)
- •Determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (MRI/CT scan) three months post final treatment
- •Life expectancy ≥ 12 weeks
- •Ability to understand study and provide legally effective written informed consent
- •Women of child-bearing potential must have a negative test within 4 weeks to the start of the SBRT treatment and must not be pregnant or nursing a child
- •Sexually active women must agree to use accepted forms of birth control throughout the study, which include abstinence, oral contraceptives (birth control pills), IUD, diaphragm with spermicide, Norplant, hormone injections, condoms with spermicide, or documentation of medical sterilization
排除标准
- •History of abdominal radiation
- •Cirrhosis classified as Child Pugh Class B with score ≥ 8
- •Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- •Evidence of metastatic disease prior to registration
- •Evidence of main portal vein thrombosis
- •History of cardiac ischemia or stroke within 6 months prior to enrollment
- •Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppressant that would constitute a contraindication to liver transplantation
- •History of sorafenib therapy within 21 days prior to enrollment
结局指标
主要结局
Tumor response rate
时间窗: 3 months
Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months
次要结局
- Tumor down staging(3 and 6 months)
- Frequency of adverse events(6 months)
- Incidence of local tumor progression(6 months)
- Number of patients eligibility for liver transplantation(3 months)
研究者
Juan Sanabria, MD
Physician Surgical Oncology
Midwestern Regional Medical Center
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