A Prospective Study of HCV-RNA Kinetics During Treatment With Sorafenib in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Decline in HCV-RNA Level
研究概览
简要总结
This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases.
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors.
The researchers of this study would like to study the effects of sorafenib on hepatitis C by drawing additional research blood samples from people infected with hepatitis C who are receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.
详细描述
This is a prospective, open-label, non-interventional trial to evaluate HCV-RNA levels during treatment with Sorafenib in patients with advanced hepatocellular carcinoma.
Participants will receive Sorafenib 400mg orally twice daily. HCV-RNA (Hepatitis C Virus - Ribonucleic Acid) levels will be measured at baseline, week 2 of sorafenib, week 4 of sorafenib, week 6 of sorafenib, week 8 of sorafenib, week 12 of sorafenib, and 2 weeks after discontinuing sorafenib. HCV-RNA levels will be measured by drawing about 2 tablespoons of blood
During the study period, tumor assessments will be done by MRI (magnetic resonance imaging) or CT (computed tomography) scans at baseline and every 8 weeks.
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
- •Histologically and/or radiologically confirmed advanced HCC
- •Detectable HCV RNA with anti-HCV-positivity
- •Life expectancy of at least 3 months
- •Willing to use adequate contraception
排除标准
- •Pregnant or breastfeeding
- •Undetectable HCV RNA
- •Uncontrolled hypertension
- •Active or clinically significant cardiac disease
- •Thrombolic, embolic, venous or arterial events within 6 months of informed consent
- •Pulmonary hemorrhage/bleeding event (NCI-CTCAE grade 2 or higher) within 4 weeks before study entry
- •Previously untreated or concurrent cancer except cervical cancer in situ, treated basal cell carcinoma or superficial bladder tumor
- •Presence of non-healing wound, ulcer or bone fracture
- •History of organ allograft
- •Known or suspected allergy or hypersensitivity to any of the study drugs
- •Any malabsorption condition
- •Inability to comply with the protocol and/or not willing or not available for follow up
- •Major surgery within 30 days prior to start of study drug
研究组 & 干预措施
Treatment Arm
Sorafenib taken orally twice per day
干预措施: Sorafenib (Drug)
结局指标
主要结局
Decline in HCV-RNA Level
时间窗: up to 2 years
Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.
次要结局
- Time to Radiological Tumor Progression(2 years)
- Overall Survival(2 years)
研究者
Andrew X. Zhu, MD
Principal Investigator
Massachusetts General Hospital