A Phase II Trial Of Rh-Endostatin In Combination With Radiotherapy In The Treatment Of Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- progress-free survival(PFS)
研究概览
简要总结
Hepatocellular carcinoma(HCC) is a high malignancy cancer which progress rapidly , and the rates of morbidity and mortality is very high in China. Radiotherapy as a effective treatment is commonly used in unresectable HCC patients. Preclinical models have shown that anti-angiogenesis medicine,such as rh-endostatin, can normalize the tumor vasculature to make it more efficient for oxygen delivery, which can enhance the radiosensitivity subsequently. This study is to evaluate the safety and efficacy of rh-endostatin combined with radiotherapy in the treatment of HCC.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically or cytologically confirmed hepatocellular carcinoma,or radiographic indicative HCC with AFP>250ug/l
- •Inoperable and untransplantable,Child-pugh score A or B
- •PS score 0-1
- •At least one measurable site(diameter >20mm measured by CT or MRI,>10mm measured by helical CT scan.
- •No distant metastases
- •Life expectancy longer than 3 months
- •Willingness and ability to comply the study and signed informed consent.
排除标准
- •Not comply the designed treatment or change to other treatment
- •Miss follow-up visits or have incomplete follow-up data
- •The efficacy will not be assessed if the Patient withdrawal the treatment due to severe adverse events(SAE),but SAE will be recorded.
- •Disease progression
- •Patients request to withdraw
- •Patients with III hematologic or Ⅳ nonhematologic drug related toxicity ,or SAE
研究组 & 干预措施
rh-endostatin combination
Continuous intravenous pumping (CIP) recombinant human endostatin(rh-endostatin) 30mg/d, from 5 days before radiotherapy,for 7days,21 per cycle.Standard radiotherapy for HCC is conducted concurrently.Those patients will receive 3-5 cycles rh-endostatin after the radiotherapy is finished,4-6 cycles in all.
干预措施: recombinant human endostatin (Drug)
结局指标
主要结局
progress-free survival(PFS)
时间窗: 18 months
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
次要结局
- clinical benefit rate(CBR)(24months)
- Quality of life (QOL)(36months)
- overall survival(OS)(36 months)
- response rate(RR)(18months)
- adverse event(AE)(36 months)
研究者
YuLi
Vice Director of Department of Radiotherappy
Chinese PLA General Hospital