Maintenance of Sorafenib Following Combined Therapy of Three-dimensional Conformal Radiation Therapy/Intensity-modulated Radiation Therapy and Transcatheter Arterial Chemoembolization in Patients With Locally Advanced Hepatocellular Carcinoma: a Phase I/II Study.
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The safety and tolerability of maintenance Sorafenib.
研究概览
简要总结
Patients with liver cancer will receive interventional therapy plus radiotherapy. Maintenance Sorafenib will be taken after the completion of radiotherapy. Hypothesis of the current study is that Sorafenib as a maintenance therapy is safe and superior to radiotherapy combined with interventional therapy in terms of survival in comparison to historical data.
详细描述
Patients with solitary lesion (bigger than 5 cm in diameter) histologically or cytologically confirmed HCC receive TACE (1-3 cycles) plus 3DCRT/IMRT 4-6 weeks later. Maintenance Sorafenib will be administered only for the patients with non-progression disease 4 to 6 weeks after the completion of radiotherapy. The dose will be 400 mg, p.o., twice a day. Sorafenib will be continuously given for 12 months unless intolerable toxicities and/or tumor progression. Hypothesis of the current study is that Sorafenib as a maintenance therapy after combined therapy of 3DCRT/IMRT and TACE is safe and superior to radiotherapy combined with TACE alone in terms of time to progression (TTP), progression-free survival (PFS) and overall survival (OS) in comparison to historical data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of equal or older than 18 years and not over 75 years with a life expectancy of at least 12 weeks;
- •Karnofsky performance status (KPS) of ≥70;
- •Histologically or cytologically confirmed HCC;
- •BCLC stage B, solitary lesion (bigger than 5 cm in diameter) with tumor burden less than 50% of total liver volume;
- •Liver function of Child-Pugh A;
- •Technically unresectable, medically inoperable, or surgery declined by the patient;
- •Normal renal function and adequate bone marrow reservation;
- •Signed informed consent must be obtained prior to any study specific procedure.
排除标准
- •Presence of intrahepatic and/or extrahepatic metastases
- •Previous received systemic therapy for liver cancer;
- •History of radiotherapy to the liver;
- •Indistinct tumor boundary on CT/MRI images;
- •Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder tumors [Ta, Tis and T1];
- •History of cardiac disease: congestive heart failure > NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months;
- •Concurrent uncontrolled medical conditions;
- •Pregnancy or breast feeding;
- •Investigational drug therapy outside of this trial during or within 4 weeks of study entry;
- •Psychiatric or medical unstable conditions that compromise the patient's ability to give informed consent.
结局指标
主要结局
The safety and tolerability of maintenance Sorafenib.
时间窗: twelve months
次要结局
- Time to progression (TTP), progression-free survival (PFS) and overall survival (OS)(30 months)