Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression
研究概览
简要总结
The purpose of this study is to learn about the effect of the investigational agent tivozanib on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also plan to collect information on the likelihood to develop side effects while on this treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is designed to stop the tumor from developing new blood vessels.
详细描述
Angiogenesis is the formation of new blood vessels. Angiogenesis is driven by cytokines including vascular endothelial growth factor. Tivozanib is an oral medication that inhibits vascular endothelial growth factor preventing tumor from developing new blood vessels.
The purpose of this study is to evaluate the effects of tivozanib on hepatocellular (liver) cancer. Participants in the study take tivozanib daily at a dose of 1 mg for 1month. if doing well the dose would be increased to 1.5 mg per day. Patients are monitored for response using CT or MRI scans every 2months. In addition, patients will have blood draws to evaluate the effects of tivozanib on blood vessels.
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
- •Patients with measurable, histological diagnosis of hepatocellular carcinoma (HCC) and whose disease is not amenable to surgical or regional therapy.
- •Prior allowed therapy:
- •Surgery including hepatic resection
- •Minimum of 4 weeks since any surgical procedure.
- •Patients must have adequately recovered from surgery.
- •Regional therapy
- •Includes transarterial chemoembolization (TACE), drug-eluting bead [DEB]-TACE, percutaneous ethanol injection, radiofrequency/cryo ablation, Yttrium-90 radioembolization.
- •More than 2 weeks must have lapsed from therapy.
- •There must be an indicator lesion outside the treated area or clear evidence of progression in the treated lesion, not amenable for further local therapies.
- •Concomitant sorafenib with regional therapy is allowed as long as no evidence of progression on sorafenib.
- •Prior adjuvant sorafenib is allowed, if completed more than 6 months prior to disease recurrence.
- •Adequate hematological, liver and metabolic organ function.
- •Signed informed consent.
排除标准
- •Patients with mixed histology or fibrolamellar variant.
- •Prior systemic therapy for metastatic disease.
- •Uncontrolled hypertension (HTN).
- •Symptomatic heart failure.
研究组 & 干预措施
Tivozanib
Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.
干预措施: Tivozanib (Drug)
结局指标
主要结局
Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression
时间窗: 6 Months
Evaluation of disease progression in the patients with advanced hepatocellular cancer (HCC) receiving tivozanib will be made using CT or MRI scan of the organ(s) with the target lesion(s). Response Evaluation Criteria In Solid Tumors (RECIST) criteria 1.1 will be used for objective tumor response assessment. Measurable lesions can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan. Target lesions are all measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.
次要结局
- Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria(6 months)
研究者
Bassel El-Rayes
Study Principal Investigator
Emory University